Breast Cancer
Conditions
Keywords
inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, HER2-negative breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer, stage IIIC breast cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.
Detailed description
OBJECTIVES: * To compare the pathologic complete response rates in women with HER2/neu-negative inflammatory or locally advanced breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, cyclophosphamide, and pegfilgrastim with vs without bevacizumab. * To compare the overall survival of patients treated with these regimens. * To assess whether there is a correlation between bevacizumab and stratification factors (type of disease and hormone receptor status). * To compare the toxicities of these regimens. * To explore the molecular biomarkers related to the biology and outcome of inflammatory breast cancer. * To explore potential molecular biomarkers that predict response to therapy and drug sensitivity. * To evaluate biomarkers with respect to the sequence of paclitaxel albumin-stabilized nanoparticle formulation and doxorubicin hydrochloride/cyclophosphamide/pegfilgrastim administration in patients not receiving bevacizumab. * To explore residual cancer burden and correlate it with outcome. * To evaluate the time to treatment failure prior to surgery. * To evaluate disease-free survival from the time of surgery in patients undergoing definitive surgery. OUTLINE: This is a multicenter study. Patients are stratified according to type of disease (inflammatory vs locally advanced breast cancer) and hormone receptor status (positive \[estrogen receptor (ER)+ and/or progesterone receptor (PgR)+\] vs negative \[ER- and PgR-\]). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24. * Arm II: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24. * Arm III: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25. In all arms, patients with stable or responding disease undergo surgery 3-6 weeks after completion of chemotherapy. Patients may then undergo radiotherapy 5 days a week for 6 weeks. Serum, whole blood, and tissue samples are collected periodically for biomarker analysis, circulating endothelial cell analysis, and pharmacogenomic studies, respectively. After completion of study treatment, patients are followed every 6 months for 1 year and then annually for 4 years.
Interventions
BIOLOGICALbevacizumab
Given IV
BIOLOGICALpegfilgrastim
Given subcutaneously
DRUGcyclophosphamide
Given IV
DRUGdoxorubicin hydrochloride
Given IV
DRUGpaclitaxel albumin-stabilized nanoparticle formulation
Given IV
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or pathologically confirmed breast cancer meeting one of the following criteria: * Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease) * Inflammatory disease meeting the following two clinicopathologic criteria: * Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50% * A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself * HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH\* * 2+ by DAKO or IHC allowed provided FISH\* negative * NOTE: \*A negative FISH test ratio is \< 1.8 or FISH HER2 gene copy \< 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry * Hormone receptor status known PATIENT CHARACTERISTICS: * Menopausal status not specified * Zubrod performance status 0-2 * Granulocyte count \> 1,500/mm\^3 * ANC ≥ 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin 9.0 g/dL * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 mg/dL * ALT and AST ≤ 3 times ULN * Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis) * Urine protein:creatinine ratio ≤ 0.5 OR urine protein \< 1,000 mg on 24-hour urine collection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome) * QTc \< 500 msec by EKG * LVEF normal by MUGA or ECHO (for patients with hypertension or for patients \> 60 years of age) * NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible) * No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following: * Myocardial infarction (including severe/unstable angina) * Coronary/peripheral artery bypass graft * Symptomatic congestive heart failure * Pulmonary embolism * No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours) elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg) * No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * Peripheral neuropathy \< grade 2 PRIOR CONCURRENT THERAPY: * No prior tyrosine kinase inhibitors * More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer * At least 7 days since prior hormonal therapy * At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice * No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort) * No other concurrent therapy for the treatment of breast cancer except for bisphosphonates * No concurrent brachytherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Pathological Complete Response Rate | pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization) | Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration. | Time from registration to death due to any cause |
| Event-free Survival | Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence | Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause. |
| Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Up to 28 weeks | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G) Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6). | 98 |
| Arm 2 (Nab-Paclitaxel / AC+PEG-G)) Received nP x 12 followed by ddAC x 6 without bevacizumab | 62 |
| Arm 3 (AC+PEG-G / Nab-Paclitaxel) Received ddAC x 6 first followed by nP x 12, without bevacizumab | 51 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible or withdrew consent | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Arm 2 (Nab-Paclitaxel / AC+PEG-G)) | Arm 3 (AC+PEG-G / Nab-Paclitaxel) | Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G) | Total |
|---|---|---|---|---|
| Age, Continuous | 49.7 years | 51.6 years | 51.7 years | 51.5 years |
| Breast cancer stage IIB | 30 Participants | 22 Participants | 35 Participants | 87 Participants |
| Breast cancer stage IIIA | 16 Participants | 14 Participants | 32 Participants | 62 Participants |
| Breast cancer stage IIIB | 12 Participants | 12 Participants | 29 Participants | 53 Participants |
| Breast cancer stage IIIC | 4 Participants | 2 Participants | 2 Participants | 8 Participants |
| Hormone receptor status Negative: ER- and PR- (TNBC) | 19 Participants | 16 Participants | 32 Participants | 67 Participants |
| Hormone receptor status Positive: ER+ or PgR+ | 43 Participants | 35 Participants | 66 Participants | 144 Participants |
| Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC) IBC | 7 Participants | 7 Participants | 10 Participants | 24 Participants |
| Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC) Non-IBC LABC | 55 Participants | 44 Participants | 88 Participants | 187 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian/Pacific Islander | 1 Participants | 5 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 14 Participants | 4 Participants | 20 Participants | 38 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other/unknown | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 44 Participants | 40 Participants | 70 Participants | 154 Participants |
| Sex: Female, Male Female | 62 Participants | 51 Participants | 98 Participants | 211 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 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 | 92 / 96 | 58 / 60 | 50 / 51 |
| serious Total, serious adverse events | 22 / 96 | 3 / 60 | 3 / 51 |
Outcome results
Primary
Number of Patients With Pathological Complete Response Rate
Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.
Time frame: pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)
Population: Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Patients With Pathological Complete Response Rate | 35 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Patients With Pathological Complete Response Rate | 24 Participants |
p-value: 0.019Chi-squared
Secondary
Event-free Survival
Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.
Time frame: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence
Population: Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Event-free Survival | 20 participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Event-free Survival | 24 participants |
p-value: 0.71Log Rank
Secondary
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 28 weeks
Population: All participants receiving at least some protocol treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Nausea | 6 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Renal and urinary disorders - Other, specify | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dental caries | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Skin infection | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Facial pain | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Lymphocyte count decreased | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Suicide attempt | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Abdominal pain | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Lung infection | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypercalcemia | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Skin and subcutaneous tissue disorders - Other | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Leukocytosis | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Gastrointestinal disorders - Other, specify | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Erythema multiforme | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hyperglycemia | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Fatigue | 7 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Enterocolitis infectious | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypertension | 8 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Vulval infection | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Enterocolitis | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Ejection fraction decreased | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypophosphatemia | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Sepsis | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Edema limbs | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Febrile neutropenia | 10 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Ear pain | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Adult respiratory distress syndrome | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Depression | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dehydration | 4 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Alanine aminotransferase increased | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Respiratory failure | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Conjunctivitis | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anemia | 13 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Gait disturbance | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Confusion | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anorectal infection | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Chest wall pain | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anxiety | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | White blood cell decreased | 15 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Catheter related infection | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Aspartate aminotransferase increased | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Rectal pain | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Bone pain | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Generalized muscle weakness | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Vomiting | 9 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Rash maculo-papular | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Headache | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Device related infection | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Heart failure | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | CD4 lymphocytes decreased | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Proteinuria | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Urinary tract infection | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Proctitis | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypokalemia | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Diarrhea | 3 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pneumonitis | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hyponatremia | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Blood and lymphatic system disorders - Other | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypotension | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Tooth infection | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Platelet count decreased | 6 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Insomnia | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dysphagia | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Peripheral sensory neuropathy | 5 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Mucositis oral | 6 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Weight loss | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Peripheral motor neuropathy | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Myalgia | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Thromboembolic event | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Periorbital infection | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Nasal congestion | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pain in extremity | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Neutrophil count decreased | 36 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dyspnea | 3 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pain | 2 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Non-cardiac chest pain | 0 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Weight gain | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Syncope | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Otitis externa | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Facial nerve disorder | 1 Participants |
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Oral pain | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | White blood cell decreased | 5 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Abdominal pain | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Blood and lymphatic system disorders - Other | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | CD4 lymphocytes decreased | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dental caries | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Depression | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Device related infection | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Diarrhea | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dysphagia | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dyspnea | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Facial nerve disorder | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Facial pain | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Fatigue | 7 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Febrile neutropenia | 5 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Gastrointestinal disorders - Other, specify | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Generalized muscle weakness | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Headache | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Heart failure | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypercalcemia | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypokalemia | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hyponatremia | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypotension | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Insomnia | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Mucositis oral | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Myalgia | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Neutrophil count decreased | 10 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Non-cardiac chest pain | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pain in extremity | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Palmar-plantar erythrodysesthesia syndrome | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Renal and urinary disorders - Other, specify | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Sepsis | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Skin infection | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Suicide attempt | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Gait disturbance | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hyperglycemia | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypertension | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypophosphatemia | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anorectal infection | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Adult respiratory distress syndrome | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Alanine aminotransferase increased | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anemia | 6 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anxiety | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Aspartate aminotransferase increased | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Bone pain | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Catheter related infection | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Chest wall pain | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Confusion | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Conjunctivitis | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dehydration | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Ear pain | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Edema limbs | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Ejection fraction decreased | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Enterocolitis | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Enterocolitis infectious | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Erythema multiforme | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Leukocytosis | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Lung infection | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Lymphocyte count decreased | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Nasal congestion | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Nausea | 6 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Oral pain | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Otitis externa | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pain | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Periorbital infection | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Peripheral motor neuropathy | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Peripheral sensory neuropathy | 5 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Platelet count decreased | 3 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pneumonitis | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Proctitis | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Proteinuria | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Rash maculo-papular | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Rectal pain | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Respiratory failure | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Skin and subcutaneous tissue disorders - Other | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Syncope | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Thromboembolic event | 2 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Tooth infection | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Urinary tract infection | 1 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Vomiting | 3 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Vulval infection | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Weight gain | 0 Participants |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Weight loss | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Lung infection | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Skin infection | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dehydration | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Lymphocyte count decreased | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Syncope | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Nasal congestion | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Rectal pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dysphagia | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Non-cardiac chest pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Palmar-plantar erythrodysesthesia syndrome | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Bone pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Oral pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pain in extremity | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Thromboembolic event | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Otitis externa | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Neutrophil count decreased | 16 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Diarrhea | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Nausea | 4 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Myalgia | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Weight gain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Periorbital infection | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Mucositis oral | 5 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Tooth infection | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Peripheral motor neuropathy | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Insomnia | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Device related infection | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Peripheral sensory neuropathy | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypotension | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | CD4 lymphocytes decreased | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Platelet count decreased | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypokalemia | 3 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Urinary tract infection | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Pneumonitis | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypercalcemia | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Depression | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Proctitis | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Heart failure | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Aspartate aminotransferase increased | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Proteinuria | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Generalized muscle weakness | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Vomiting | 2 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Rash maculo-papular | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Blood and lymphatic system disorders - Other | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Gastrointestinal disorders - Other, specify | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anxiety | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dental caries | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Catheter related infection | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anorectal infection | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Renal and urinary disorders - Other, specify | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Chest wall pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Anemia | 13 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Febrile neutropenia | 3 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Confusion | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Alanine aminotransferase increased | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Weight loss | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Conjunctivitis | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Adult respiratory distress syndrome | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Respiratory failure | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Abdominal pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Fatigue | 4 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Ear pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypophosphatemia | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Sepsis | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Edema limbs | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hyponatremia | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Facial pain | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Ejection fraction decreased | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hypertension | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Vulval infection | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Enterocolitis | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Hyperglycemia | 4 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Skin and subcutaneous tissue disorders - Other | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Enterocolitis infectious | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Headache | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Facial nerve disorder | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Erythema multiforme | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Gait disturbance | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Suicide attempt | 0 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Leukocytosis | 1 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | White blood cell decreased | 12 Participants |
| Arm III (AC+PEG-G - Nab-Paclitaxel) | Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | Dyspnea | 1 Participants |
Secondary
Overall Survival
Time from registration to death due to any cause
Time frame: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.
Population: Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) | Overall Survival | 14 deaths |
| Arm 2/3 (Nab-Paclitaxel/AC+PEG-G)) | Overall Survival | 17 deaths |
p-value: 0.64Log Rank