Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage IV breast cancer
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression. PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
Detailed description
OBJECTIVES: Primary * Determine whether women with metastatic breast cancer and elevated circulating tumor cells (CTCs) (≥ 5 per 7.5 mL of whole blood) after 3 weeks of first-line chemotherapy derive increased overall survival from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen. * Determine whether these patients derive increased progression-free survival (PFS) from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen. * Confirm previous findings that patients with \< 5 CTCs per 7.5 mL of whole blood on initial screening have longer median OS and PFS than patients with ≥ 5 CTCs per 7.5 mL of whole blood. * Determine the prognostic value of sequentially collected CTC values in these patients. * Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms. Secondary * Compare the prognostic and predictive value of CTC number vs breast cancer tumor markers, including CA 15-3 and carcinoembryonic antigen. * Create a serum specimen bank for future biologic investigation. OUTLINE: This is a partially blinded, partially randomized, multicenter study. Patients are assigned to 1 of 3 groups based on circulating tumor cells (CTCs) after 1 course of chemotherapy. All patients undergo blood collection before their first dose of first-line chemotherapy\* to determine baseline CTC count. Patients with \< 5 CTCs at baseline are assigned to group I. Patients with ≥ 5 CTCs at baseline undergo a second blood draw on day 22 (after completion of 1 course of chemotherapy). Patients with \< 5 CTCs after completing 1 course of chemotherapy are assigned to group 2. Patients with ≥ 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3. NOTE: \*Chemotherapy may be initiated while waiting for the baseline CTC result. * Group 1 (low risk of early progression): Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected. * Group 2 (moderate risk of early progression): Patients continue to receive their current chemotherapy regimen without change. * Group 3 (high risk of early progression): Patients are stratified according to HER-2 status (positive vs negative) and disease type (bone-only vs measurable disease). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients continue with their current chemotherapy regimen without change. * Arm II: Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor. Patients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level. In groups 2 and 3, blood is collected periodically during chemotherapy and then at the completion of chemotherapy. Samples are examined for CTCs via the CellSearch™ blood test. Blood is also tested for CA 15-3 and carcinoembryonic antigen (CEA). After completion of study therapy, patients are followed for up to 5 years. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Interventions
DRUGchemotherapy
No administration details available
Sponsors
National Cancer Institute (NCI)
Cancer and Leukemia Group B
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Clinical evidence of metastatic disease (stage IV disease) * Newly metastatic disease OR progressive metastatic disease while on hormonal therapy * Meets 1 of the following criteria: * Measurable disease * Bone-only disease\* NOTE: \*Patients with nonmeasurable disease that does not include bone are not eligible * HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay * HER-2 positivity is defined as IHC 3+ or FISH+ * If IHC is indeterminate (2+), FISH must be performed to classify disease * Planning to undergo first-line chemotherapy for metastatic disease * Patients with brain metastases must have stable disease for \> 90 days after completion of prior radiotherapy to the brain * No leptomeningeal disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Zubrod performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed * Any number of exogenous hormonal therapies for metastatic disease and/or as adjuvant therapy allowed * At least 1 year since prior adjuvant chemotherapy * At least 2 weeks since prior minor surgery and recovered * At least 4 weeks since prior major surgery and recovered * No prior chemotherapy for metastatic disease * Concurrent hormonal therapy and/or bisphosphonate therapy allowed * Concurrent trastuzumab and/or bevacizumab allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Every 3 months until progression then every 6 months for 5 years or until death | From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Progression-free Survival | every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years. | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Progression Free Survival | every 3 months until progression | From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression | Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Other
| Measure | Time frame |
|---|---|
| Correlation of CTC Levels With Breast Cancer Tumor Markers | Baseline, Weeks 4, 8, 13, 25, 37 and at progression |
Countries
United States
Participant flow
Pre-assignment details
624 patients were registered for screening. 29 patients were excluded due to initial CTC test not completed(17) and ineligible(12). 276 did not have increased CTC levels (Arm A). 319 patients had increased CTC levels. Additional 31 patients were excluded from 319 due to no CTC values on Day 21. Thus total 288 patients in ArmB, ArmC2 and ArmC2.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Baseline CTCs < 5, Low Risk) Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS). | 276 |
| Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but \< 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized. | 165 |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and \>= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy. | 64 |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and \>= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs. | 59 |
| Total | 564 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 9 | 7 | 11 |
| Overall Study | Other, not protocol specified | 0 | 16 | 3 | 1 |
| Overall Study | Progression | 0 | 136 | 51 | 43 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 3 | 4 |
Baseline characteristics
| Characteristic | Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) | Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Arm A (Baseline CTCs < 5, Low Risk) | Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Total |
|---|---|---|---|---|---|
| Age, Customized Age 55 years or older | 94 Participants | 38 Participants | 163 Participants | 39 Participants | 334 Participants |
| Black Race | 23 Participants | 15 Participants | 50 Participants | 7 Participants | 95 Participants |
| HER2 positive | 36 Participants | 3 Participants | 53 Participants | 4 Participants | 96 Participants |
| Homo receptor positive, HER2 negative | 93 Participants | 50 Participants | 148 Participants | 39 Participants | 330 Participants |
| Measurable disease | 137 Participants | 47 Participants | 221 Participants | 50 Participants | 455 Participants |
| No. of patients classified by disease subtype | 162 Participants | 64 Participants | 275 Participants | 59 Participants | 560 Participants |
| Sex: Female, Male Female | 165 Participants | 64 Participants | 276 Participants | 59 Participants | 564 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Triple negative | 33 Participants | 11 Participants | 74 Participants | 16 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 152 / 161 | 57 / 64 | 53 / 56 |
| serious Total, serious adverse events | 0 / 161 | 1 / 64 | 0 / 56 |
Outcome results
Primary
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Every 3 months until progression then every 6 months for 5 years or until death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Overall Survival | 10.7 months |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Overall Survival | 12.5 months |
Comparison: Hazard Ration of overall survival compared Arm C2 to Arm C1.p-value: 0.9895% CI: [0.69, 1.47]Log Rank
Primary
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Every 3 months until progression then every 6 months for 5 years or until death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Overall Survival | 35 months |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Overall Survival | 23 months |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Overall Survival | 13 months |
Primary
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.
Population: Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Progression-free Survival | 3.5 months |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Progression-free Survival | 4.6 months |
Comparison: Hazard Ratio of progression free survival compared Arm C2 to Arm C1p-value: 0.6495% CI: [0.64, 1.32]Log Rank
Primary
Progression Free Survival
From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: every 3 months until progression
Population: Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Progression Free Survival | 11.1 months |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Progression Free Survival | 8.9 months |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Progression Free Survival | 4.9 months |
Secondary
Number of Patients With Adverse Events That Are Related to Study Drugs
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Population: Patients in 'Arm A (Baseline CTCs \< 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Oral-gums | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Lymphopenia | 8 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Magnesium, serum-low (hypomagnesemia) | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Memory impairment | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Metabolic/Laboratory-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mood alteration - anxiety | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mood alteration - depression | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Oral cavity | 10 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (functional/symp) - Oral cav | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-lower | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-upper | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Musculoskeletal/Soft Tissue-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nail changes | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nasal cavity/paranasal sinus reactions | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nausea | 27 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neuropathy: motor | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neuropathy: sensory | 23 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neutrophils/granulocytes (ANC/AGC) | 71 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ocular/Visual-Other (Specify) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Osteonecrosis (avascular necrosis) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Abdomen NOS | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Back | 6 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Bladder | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Bone | 27 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Breast | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Chest wall | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Chest/thorax NOS | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Extremity-limb | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Face | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Head/headache | 5 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Joint | 8 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Muscle | 10 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Neck | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Neuralgia/peripheral nerve | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Oral cavity | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Leukocytes (total WBC) | 28 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Pain NOS | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Pelvis | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Rectum | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Scalp | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Stomach | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Throat/pharynx/larynx | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Vagina | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain-Other (Specify) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Platelets | 42 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pleural effusion (non-malignant) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pneumonitis/pulmonary infiltrates | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Potassium, serum-high (hyperkalemia) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Potassium, serum-low (hypokalemia) | 4 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Proteinuria | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pruritus/itching | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pulmonary/Upper Respiratory-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash/desquamation | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash: acne/acneiform | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash: hand-foot skin reaction | 10 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Renal/Genitourinary-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Restrictive cardiomyopathy | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Retinopathy | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rigors/chills | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial tachycardia/PAT | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Sinus tachycardia | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sodium, serum-high (hypernatremia) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sodium, serum-low (hyponatremia) | 6 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sweating (diaphoresis) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Syndromes-Other (Specify) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Taste alteration (dysgeusia) | 6 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Thrombosis/thrombus/embolism | 5 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Thyroid function, high | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Triglyceride, serum-high (hypertriglyceridemia) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Urinary frequency/urgency | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vaginal dryness | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vision-blurred vision | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vomiting | 38 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Watery eye (epiphora, tearing) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Weight loss | 8 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | ALT, SGPT (serum glutamic pyruvic transaminase) | 8 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | AST, SGOT | 10 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Albumin, serum-low (hypoalbuminemia) | 5 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Alkaline phosphatase | 7 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergic reaction/hypersensitivity | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergic rhinitis | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergy/Immunology-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Anorexia | 16 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ascites (non-malignant) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Auditory/Ear-Other (Specify) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Bilirubin (hyperbilirubinemia) | 5 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Blood/Bone Marrow-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | CNS cerebrovascular ischemia | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Calcium, serum-high (hypercalcemia) | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Calcium, serum-low (hypocalcemia) | 5 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Confusion | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Constipation | 12 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Constitutional Symptoms-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Cough | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Creatinine | 15 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dehydration | 17 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dermatology/Skin-Other (Specify) | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Diarrhea | 55 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Distention/bloating, abdominal | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dizziness | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry eye syndrome | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry mouth/salivary gland (xerostomia) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry skin | 5 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dyspnea (shortness of breath) | 18 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Edema: head and neck | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Edema: limb | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Fatigue (asthenia, lethargy, malaise) | 103 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 6 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Flatulence | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Flushing | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Gastrointestinal-Other (Specify) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Glucose, serum-high (hyperglycemia) | 13 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Glucose, serum-low (hypoglycemia) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hair loss/Alopecia (scalp or body) | 20 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Heartburn/dyspepsia | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemoglobin | 100 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, Respiratory tract NOS | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Stomach | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, GU - Uterus | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Nose | 7 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hot flashes/flushes | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hyperpigmentation | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hypertension | 6 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hypotension | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ileus, GI (functional obstruction of bowel) | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Induration/fibrosis (skin and subcutaneous tissue) | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Nose | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 3 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Up airway | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Sinus | 1 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Skin (cellulitis) | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection-Other (Specify) | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Injection site reaction/extravasation changes | 0 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Insomnia | 2 Participants |
| Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Left ventricular systolic dysfunction | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Potassium, serum-high (hyperkalemia) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Potassium, serum-low (hypokalemia) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Glucose, serum-high (hyperglycemia) | 4 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Proteinuria | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pruritus/itching | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pulmonary/Upper Respiratory-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Glucose, serum-low (hypoglycemia) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash/desquamation | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash: acne/acneiform | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash: hand-foot skin reaction | 4 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hair loss/Alopecia (scalp or body) | 5 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Renal/Genitourinary-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Restrictive cardiomyopathy | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Retinopathy | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Heartburn/dyspepsia | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rigors/chills | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial tachycardia/PAT | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Sinus tachycardia | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemoglobin | 32 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sodium, serum-high (hypernatremia) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sodium, serum-low (hyponatremia) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sweating (diaphoresis) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, Respiratory tract NOS | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Syndromes-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Taste alteration (dysgeusia) | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Thrombosis/thrombus/embolism | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Stomach | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Thyroid function, high | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Triglyceride, serum-high (hypertriglyceridemia) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Urinary frequency/urgency | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, GU - Uterus | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vaginal dryness | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vision-blurred vision | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Injection site reaction/extravasation changes | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vomiting | 10 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Nose | 4 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Watery eye (epiphora, tearing) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Weight loss | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Up airway | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | ALT, SGPT (serum glutamic pyruvic transaminase) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hot flashes/flushes | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | AST, SGOT | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Albumin, serum-low (hypoalbuminemia) | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Alkaline phosphatase | 5 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hyperpigmentation | 3 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergic reaction/hypersensitivity | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergic rhinitis | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergy/Immunology-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hypertension | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Anorexia | 5 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ascites (non-malignant) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Sinus | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Auditory/Ear-Other (Specify) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hypotension | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Bilirubin (hyperbilirubinemia) | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Blood/Bone Marrow-Other (Specify) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | CNS cerebrovascular ischemia | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ileus, GI (functional obstruction of bowel) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Calcium, serum-high (hypercalcemia) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Calcium, serum-low (hypocalcemia) | 3 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Left ventricular systolic dysfunction | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Confusion | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Induration/fibrosis (skin and subcutaneous tissue) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Constipation | 5 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Constitutional Symptoms-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Cough | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Creatinine | 5 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dehydration | 6 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Leukocytes (total WBC) | 11 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Lymphopenia | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Magnesium, serum-low (hypomagnesemia) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dermatology/Skin-Other (Specify) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Memory impairment | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Metabolic/Laboratory-Other (Specify) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mood alteration - anxiety | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Diarrhea | 10 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mood alteration - depression | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Oral cavity | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (functional/symp) - Oral cav | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Distention/bloating, abdominal | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-lower | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nausea | 10 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Insomnia | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dizziness | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Musculoskeletal/Soft Tissue-Other (Specify) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nail changes | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nasal cavity/paranasal sinus reactions | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry eye syndrome | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neuropathy: motor | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neuropathy: sensory | 3 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry mouth/salivary gland (xerostomia) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neutrophils/granulocytes (ANC/AGC) | 23 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ocular/Visual-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Urinary tract NOS | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Osteonecrosis (avascular necrosis) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry skin | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Abdomen NOS | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Back | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Bladder | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dyspnea (shortness of breath) | 9 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Bone | 8 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Breast | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Chest wall | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Edema: head and neck | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Chest/thorax NOS | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Extremity-limb | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Face | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Edema: limb | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Head/headache | 2 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Joint | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Nose | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Muscle | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Fatigue (asthenia, lethargy, malaise) | 36 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Neck | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Neuralgia/peripheral nerve | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Oral cavity | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Oral-gums | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Pain NOS | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Pelvis | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 3 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Rectum | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Scalp | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Stomach | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Flatulence | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Throat/pharynx/larynx | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Vagina | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain-Other (Specify) | 3 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Flushing | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Platelets | 16 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection-Other (Specify) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pleural effusion (non-malignant) | 0 Participants |
| Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Gastrointestinal-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Gastrointestinal-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Bone | 9 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Potassium, serum-high (hyperkalemia) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Leukocytes (total WBC) | 10 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dehydration | 7 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Potassium, serum-low (hypokalemia) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dyspnea (shortness of breath) | 9 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Lymphopenia | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Proteinuria | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Glucose, serum-high (hyperglycemia) | 7 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pruritus/itching | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Flatulence | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pulmonary/Upper Respiratory-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Magnesium, serum-low (hypomagnesemia) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Breast | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash/desquamation | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Glucose, serum-low (hypoglycemia) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash: acne/acneiform | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Memory impairment | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rash: hand-foot skin reaction | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dermatology/Skin-Other (Specify) | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Pain NOS | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Renal/Genitourinary-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hair loss/Alopecia (scalp or body) | 5 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Restrictive cardiomyopathy | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Chest wall | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Insomnia | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Retinopathy | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mood alteration - anxiety | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Flushing | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Rigors/chills | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Heartburn/dyspepsia | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Chest/thorax NOS | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial tachycardia/PAT | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mood alteration - depression | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Sinus tachycardia | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Diarrhea | 15 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Edema: head and neck | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sodium, serum-high (hypernatremia) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemoglobin | 38 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Oral cavity | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sodium, serum-low (hyponatremia) | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Left ventricular systolic dysfunction | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Sweating (diaphoresis) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Pelvis | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Syndromes-Other (Specify) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, Respiratory tract NOS | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Extremity-limb | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Taste alteration (dysgeusia) | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-lower | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Thrombosis/thrombus/embolism | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Distention/bloating, abdominal | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Vagina | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Thyroid function, high | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Stomach | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Triglyceride, serum-high (hypertriglyceridemia) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Face | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Urinary frequency/urgency | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Rectum | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vaginal dryness | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, GU - Uterus | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - body/general | 5 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vision-blurred vision | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Head/headache | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Edema: limb | 6 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Vomiting | 14 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Musculoskeletal/Soft Tissue-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dizziness | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Watery eye (epiphora, tearing) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Weight loss | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nail changes | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Joint | 4 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | ALT, SGPT (serum glutamic pyruvic transaminase) | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nasal cavity/paranasal sinus reactions | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | AST, SGOT | 6 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hot flashes/flushes | 4 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Scalp | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Albumin, serum-low (hypoalbuminemia) | 4 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Up airway | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Nausea | 10 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Alkaline phosphatase | 8 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry eye syndrome | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Muscle | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergic reaction/hypersensitivity | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hyperpigmentation | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neuropathy: motor | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergic rhinitis | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Injection site reaction/extravasation changes | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Allergy/Immunology-Other (Specify) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain-Other (Specify) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neuropathy: sensory | 5 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Anorexia | 9 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hypertension | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Platelets | 23 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ascites (non-malignant) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Neck | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Neutrophils/granulocytes (ANC/AGC) | 25 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Auditory/Ear-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry mouth/salivary gland (xerostomia) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Fatigue (asthenia, lethargy, malaise) | 36 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Bilirubin (hyperbilirubinemia) | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Hypotension | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ocular/Visual-Other (Specify) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Blood/Bone Marrow-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Sinus | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Stomach | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | CNS cerebrovascular ischemia | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Neuralgia/peripheral nerve | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Osteonecrosis (avascular necrosis) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Calcium, serum-high (hypercalcemia) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Ileus, GI (functional obstruction of bowel) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Nose | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Calcium, serum-low (hypocalcemia) | 4 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pleural effusion (non-malignant) | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Abdomen NOS | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Confusion | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Dry skin | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Oral cavity | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Constipation | 6 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Induration/fibrosis (skin and subcutaneous tissue) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Back | 3 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Constitutional Symptoms-Other (Specify) | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Phosphate, serum-low (hypophosphatemia) | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Throat/pharynx/larynx | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Cough | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Bladder | 0 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Pain - Oral-gums | 1 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Creatinine | 2 Participants |
| Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) | Number of Patients With Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 0 Participants |
Other Pre-specified
Correlation of CTC Levels With Breast Cancer Tumor Markers
Time frame: Baseline, Weeks 4, 8, 13, 25, 37 and at progression