Metastatic Breast Cancer
Conditions
Keywords
Hormone, Receptor, Positive, Metastatic, Breast, Cancer
Brief summary
The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.
Interventions
DRUGfulvestrant
Fulvestrant will be given at 500mg on Day 1 followed by 250 mg on Days 15 and 29, then 250mg every 28 days(Q28d).
DRUGcapecitabine
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight \< 80 Kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 Kg.
Sponsors
Hoffmann-La Roche
AstraZeneca
Accelerated Community Oncology Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * At least 18 years of age. * Post-menopausal female (ie, amenorrheic for at least 12 months prior to study entry). Post-menopausal status will be confirmed by drawing follicle stimulating hormone (FSH) and estradiol levels if \< 2 years since last menses. * Ambulatory outpatient with Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 2 at study entry. * Primary tumor human epidermal growth factor receptor 2 (HER-2) negative at study entry.(Investigator discretion will be used in instances of immuno-histochemistry \[IHC\] 2+.) * Histologically or cytologically confirmed MBC. * Primary tumor and/or metastatic lesion estrogen receptor + and/or progesterone receptor + by IHC. * At least one measurable or evaluable(non-measurable) lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (see Appendix 11.6) which has not been irradiated (i.e., newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable but are considered evaluable (non-measurable). Minimum indicator lesion size for measurable disease: ≥10 mm measured by spiral computed tomography (CT) or ≥20 mm measured by conventional techniques. * Adequate hematologic, renal, and hepatic function. * Hematologic values: Neutrophils (ANC) \> 1.5 x 109/L; Platelet count \> 100 x 109/L. * Renal function: estimated creatinine clearance \> 30 mL/min as calculated with Cockcroft-Gault equation. * Note: In patients with moderate renal impairment (calculated creatinine clearance 30 to 50 mL/min) at baseline, a dose reduction to (-1) of the capecitabine starting dose is required. * Serum bilirubin \< 1.5 x upper limit normal (ULN). * Alanine transaminase (ALT) or aspartate transaminase (AST) \< 2.5 x ULN (or \< 5 x ULN in the case of liver metastases). * Alkaline phosphatase \< 2.5 x ULN (or \< 5 x ULN in the case of liver metastases or \< 10 x ULN in the case of bone disease). * International normalization ratio (INR) \< 1.6. * Must have ≤ 1 prior regimen of endocrine therapy for metastatic breast cancer. This would include patients who have a recurrence while on adjuvant hormone therapy OR have first recurrence after adjuvant hormone therapy OR progressed after first line hormone therapy for metastatic breast cancer OR treatment naïve patients who present with metastatic breast cancer.
Exclusion criteria
* Prior administration of capecitabine. * Prior administration of fulvestrant. * Prior chemotherapy for metastatic breast cancer. * Radiotherapy ≤ 2 weeks prior to registration, except if to a non-target lesion only or single-dose radiation for palliation. NOTE: Prior radiation to a target lesion(s) is permitted only if there has been clear progression of the lesion since radiation was completed. * Life expectancy \<3 months. * Serious, uncontrolled, concurrent infection(s). * Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency. * Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cervical cancer or superficial bladder tumors (stage Ta or Tis). * Participation in any investigational drug study within 4 weeks preceding the start of study treatment. * Clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication)or myocardial infarction within the last 12 months prior to study entry. * Active brain metastases. Patients with neurological symptoms must undergo a CT scan or magnetic resonance imaging (MRI) of the brain to exclude active brain metastasis. NOTE: Patients with treated brain metastases are eligible provided they have no evidence of disease and are off definitive therapy (including steroids) ≥ 3 months prior to study entry. * Central nervous system (CNS) disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. * Known human immunodeficiency virus or chronic hepatitis B or C. * Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. * Major surgery within 4 weeks of the start of study treatment, without complete recovery. * Lack of physical integrity of the upper GI tract or malabsorption syndrome. * Known, existing uncontrolled coagulopathy. * Any of the following laboratory values: * Abnormal hematologic values (neutrophils \[ANC\]: \<1.5 × 109/L, platelet count: \<100 × 109/L) * Impaired renal function (estimated creatinine clearance: \<30 mL/min as calculated with Cockcroft-Gault equation). Note: In patients with moderate renal impairment (calculated creatinine clearance: 30 to 50 mL/min) at baseline, a dose reduction to (-1) of the capecitabine starting dose is required. * Serum bilirubin \>1.5 × upper normal limit (ULN). * Alanine transaminase (ALT) or aspartate transaminase (AST) \>2.5 × ULN (or \>5 × ULN in the case of liver metastases). * Alkaline phosphatase \> 2.5 × ULN (or \>5 × ULN in the case of liver metastases or \>10 × ULN in the case of bone disease). * International normalization ratio (INR) \>1.6. * History of: * Bleeding diathesis,(ie, disseminated intravascular coagulation \[DIC\], clotting factor deficiency) or * Long-term anticoagulant therapy,(other than antiplatelet therapy and warfarin 1 mg qd for port prophylaxis). * History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol). * Unwillingness to give written informed consent. * Unwillingness to participate or inability to comply with the protocol for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression (TTP) | TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months. | Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP. |
| Progression-free Survival (PFS) | PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months. | Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response | Response to treatment was assessed after every 8 weeks of treatment | Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. |
| Overall Response Rate | Response to treatment was assessed after every 8 weeks of treatment | Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions. |
| Clinical Benefit Rate | Response to treatment was assessed after every 8 weeks of treatment | Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of \>=20%. |
| Patients Experiencing Severe Symptom Burden (Physical Symptoms) | The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment. | The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item. |
| Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment. | The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item. |
| Patients Experiencing Severe Symptom Burden (Physical Functioning) | The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment. | The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item. |
Countries
United States
Participant flow
Recruitment details
5 community oncology research sites across the US associated with ACORN participated in this study. Enrollment started in February 2008 and was completed in May 2010.
Pre-assignment details
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group: Capecitabine/Fulvestrant Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Treatment Group: Capecitabine/Fulvestrant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age Continuous | 64.5 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 41 |
| serious Total, serious adverse events | 9 / 41 |
Outcome results
Primary
Progression-free Survival (PFS)
Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Time frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.
Population: 21 patients had experienced disease progression, and three had died. 17 patients were censored in PFS analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capecitabine and Fulvestrant | Progression-free Survival (PFS) | 14.98 Months |
Primary
Time to Progression (TTP)
Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.
Time frame: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.
Population: 21 patients had experienced disease progression. 20 patients were censored in TTP analysis. The 3 deaths in the PFS analysis were censored for the TTP analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Capecitabine and Fulvestrant | Time to Progression (TTP) | 26.94 Months | 95% Confidence Interval 1.84 |
Secondary
Best Overall Response
Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Time frame: Response to treatment was assessed after every 8 weeks of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine and Fulvestrant | Best Overall Response | Complete response (CR) | 2 participants |
| Capecitabine and Fulvestrant | Best Overall Response | Partial response (PR) | 8 participants |
| Capecitabine and Fulvestrant | Best Overall Response | Stable disease (SD) | 28 participants |
| Capecitabine and Fulvestrant | Best Overall Response | Progressive disease (PD) | 3 participants |
Secondary
Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of \>=20%.
Time frame: Response to treatment was assessed after every 8 weeks of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine and Fulvestrant | Clinical Benefit Rate | 58.5 percentage of participants |
Secondary
Overall Response Rate
Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Time frame: Response to treatment was assessed after every 8 weeks of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine and Fulvestrant | Overall Response Rate | 24.4 percentage of participants |
Secondary
Patients Experiencing Severe Symptom Burden (Physical Functioning)
The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item.
Time frame: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.
Population: Participants who had questionnaire data available. Note that 4 items only had data available from 27 participants rather than 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Attend paid job (N=27) | 37.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Attend social activity | 7.1 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Bathe or dress self | 10.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Driving (N=27) | 25.9 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Function normally | 14.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Hard work or activity (N=27) | 33.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Household work | 21.4 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Light work or activity | 10.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Run (N=27) | 33.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Run errands | 17.9 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Sit up | 10.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Stay out of bed | 7.1 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Walk | 17.9 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Functioning) | Cook for self | 10.7 percentage of participants |
Secondary
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item.
Time frame: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.
Population: Participants who had questionnaire data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Hives/Welts | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Sinus problems | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Swelling | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Fatigue | 26.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Weight loss | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Change in taste | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Difficulty hearing | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Reduced sexual enjoyment, interest, or performance | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Dry eyes | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Tearing | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Trouble seeing | 16.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Constipation | 20.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Decrease in appetite | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Diarrhea | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Heartburn | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Increase in appetite | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Problem with urination | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Vaginal dryness | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Bruising | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | New lump/mass | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Breast tenderness | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Dry skin | 13.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Hair loss | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Itching | 13.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Nails change | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Joint pain | 26.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Muscle aches | 26.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Weakness of body parts | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Burning sensation in hands or feet | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Daytime sleepiness | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Dizziness/lightheadedness | 3.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Memory loss | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Numbness/tingling | 13.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Trouble thinking | 10.0 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Headache | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Pain | 26.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Coughing | 13.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Shortness of breath | 6.7 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Physical Symptoms) | Wheezing | 6.7 percentage of participants |
Secondary
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item.
Time frame: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.
Population: Participants who had questionnaire data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Crying/feeling like crying | 10.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Feeling helpless | 6.9 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Feeling hopeless | 10.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Feeling I would be better off dead | 3.4 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Lost interest in people | 3.4 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Lost interest in pleasurable activities | 10.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Nervous, tense, anxious | 13.8 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Sad/depressed | 10.3 percentage of participants |
| Capecitabine and Fulvestrant | Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms) | Worry | 10.3 percentage of participants |
Post Hoc
Overall Survival (OS)
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Time frame: OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.
Population: 14 patients had died, and 27 patients were censored in the OS analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Capecitabine and Fulvestrant | Overall Survival (OS) | 28.65 Months |