Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Detailed description
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast. Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.
Interventions
DRUGDocetaxel
Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles. Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1.
DRUGCapecitabine
Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
Sponsors
Georgia Center for Oncology Research & Education
Sanofi
Emory University
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
* Histologically or cytologically confirmed breast carcinoma. * Early stage breast cancer (stage 1, 2, 3). * No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes. * 18 years of age or older. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Exclusion criteria
* Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. * Major surgery within 28 days of study entry. * Evidence of central nervous system (CNS) metastases. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | 1 year | Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or \<25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long Term Follow up Data on Recurrence and Survival | 2 years | Number of Patients remained alive and relapse free |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A:Sequential Therapy Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks). | 25 |
| Arm B:Concurrent Therapy Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks). | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Progression of disease | 7 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm B:Concurrent Therapy | Arm A:Sequential Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Customized | 49.8 participants | 50.8 participants | 50.3 participants |
| Region of Enrollment United States | 26 participants | 25 participants | 51 participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 25 | 26 / 26 |
| serious Total, serious adverse events | 6 / 25 | 11 / 26 |
Outcome results
Primary
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or \<25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A:Sequential Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Pathologic Complete Response-Overall population | 2 participants |
| Arm A:Sequential Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Overall Clinical Response | 15 participants |
| Arm A:Sequential Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Stable disease | 3 participants |
| Arm A:Sequential Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Progressive Disease | 7 participants |
| Arm B:Concurrent Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Progressive Disease | 2 participants |
| Arm B:Concurrent Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Pathologic Complete Response-Overall population | 3 participants |
| Arm B:Concurrent Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Stable disease | 1 participants |
| Arm B:Concurrent Therapy | Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. | Overall Clinical Response | 23 participants |
Secondary
Long Term Follow up Data on Recurrence and Survival
Number of Patients remained alive and relapse free
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A:Sequential Therapy | Long Term Follow up Data on Recurrence and Survival | 19 participants |
| Arm B:Concurrent Therapy | Long Term Follow up Data on Recurrence and Survival | 21 participants |