BRCA1 Hereditary Breast and Ovarian Cancer Syndrome
Conditions
Brief summary
Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. Triple negative breast cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a prospective, randomized, open-label, phase II study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.
Interventions
DRUGDoxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
DRUGCarboplatin
Carboplatin AUC 1,5 once a week, for 12 weeks
DRUGPaclitaxel
80mg/m2 weekly for 12 weeks
DRUGCyclophosphamide
600mg/m2 4 cycles each 21 days
Sponsors
Barretos Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Triple Negative Breast Cancer; * Stage II or III; * Performance Status ECOG \<2 or Karnofsky \>50%; * Hematologic (minimal values): Absolute neutrophil count \> 1,500/mm3 Hemoglobin \> 10.0 g/dl Platelet count \> 100,000/mm3
Exclusion criteria
* Stage I or IV; * other malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes. | within the first 21 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS) | within the first 60 month after surgery |
| Overall survival (OS) | within the first 60 month after surgery |
Countries
Brazil
Outcome results
None listed