A Phase 4 interventional study of capecitabine [Xeloda] and Taxotere in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 38 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-10.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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This study's enrollment of 157 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Drug: capecitabine [Xeloda] · Drug: Taxotere · Drug: Herceptin (HER2-neu positive patients only)
Drug: capecitabine [Xeloda] · Drug: Taxotere
Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.
Time frame: at the time of definitive surgery; after four 3-week cycles (3-4 months)
Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.
Time frame: at the time of definitive surgery; after four 3-week cycles (3-4 months)
Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))
The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.
Time frame: post 2 and 4, 3-week cycles of treatment
Percentage of Participants With Local Recurrence
Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.
Time frame: 30 - 1102 days
Participants With Disease-Free Survival
Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.
Time frame: 30 - 1102 days
Participants With Overall Survival
Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.
Time frame: 22 - 1191 days
| Milestone | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Started | 123 | 34 |
| Pathological response | 101 | 28 |
| Clinical response | 122 | 34 |
| Safety population | 122 | 34 |
| Quality of life population | 118 | 33 |
| Postoperative | 98 | 27 |
| Completed | 122 | 34 |
| Not completed | 1 | 0 |
| Withdrew: Randomized but not dosed | 1 | 0 |
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.
| percentage of participants | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery | 15.8 (9.7 to 25.4) | 50.0 (31.9 to 71.3) |
Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.
| percentage of participants | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery | 9.9 (5.1 to 18.1) | 35.7 (19.4 to 57.6) |
The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.
| percentage of participants | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) | 23.8 (18.6 to 35.9) | 23.5 (12.3 to 45.9) |
Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.
| percentage of participants | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Percentage of Participants With Local Recurrence | 3.1 (0.6 to 8.7) | 3.7 (0.1 to 19.0) |
Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.
| participants | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Participants With Disease-Free Survival | 92 | 25 |
Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.
| participants | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Participants With Overall Survival | 118 | 32 |
Collected over Cycle 1, Cycle 2, Cycle 3, Cycle 4, at Surgery, and the month 1 visit during the postoperative follow-up period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HER2-Neu Negative | — | 15/122 (12.3%) | 121/122 (99.2%) |
| HER2-Neu Positive | — | 7/34 (20.6%) | 33/34 (97.1%) |
| Event | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| febrile neutropeniaBlood and lymphatic system disorders | 4/122 | 1/34 |
| PneumoniaInfections and infestations | 1/122 | 1/34 |
| InfectionInfections and infestations | 0/122 | 1/34 |
| Perirectal abscessInfections and infestations | 0/122 | 1/34 |
| NeutropeniaBlood and lymphatic system disorders | 0/122 | 1/34 |
| International normalised ratio increasedInvestigations | 0/122 | 1/34 |
| Prothrombin time prolongedInvestigations | 0/122 | 1/34 |
| PresyncopeNervous system disorders | 0/122 | 1/34 |
| NephrolithiasisRenal and urinary disorders | 0/122 | 1/34 |
| HypotensionVascular disorders | 0/122 | 1/34 |
| Event | HER2-Neu Negative | HER2-Neu Positive |
|---|---|---|
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 57/122 | 21/34 |
| FatigueGeneral disorders | 62/122 | 20/34 |
| NauseaGastrointestinal disorders | 57/122 | 19/34 |
| DiarrhoeaGastrointestinal disorders | 51/122 | 19/34 |
| AlopeciaSkin and subcutaneous tissue disorders | 59/122 | 12/34 |
| StomatitisGastrointestinal disorders | 18/122 | 14/34 |
| InsomniaPsychiatric disorders | 27/122 | 12/34 |
| AnaemiaBlood and lymphatic system disorders | 7/122 | 10/34 |
| NeutropeniaBlood and lymphatic system disorders | 31/122 | 9/34 |
| ConstipationGastrointestinal disorders | 30/122 | 6/34 |
| Age Continuous(years) | HER2-Neu Negative | HER2-Neu Positive | Total |
|---|---|---|---|
| Mean | 51.0 ± 11.20 | 52.2 ± 9.36 | 51.3 ± 10.79 |
| Sex: Female, Male(Participants) | HER2-Neu Negative | HER2-Neu Positive | Total |
|---|---|---|---|
| Female | 122 | 34 | 156 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab