Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: BRCA1 Hereditary Breast and Ovarian Cancer Syndrome

Treatments: Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02978495

BarretosCH - 20162

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

A- BRCA Mutation

Experimental group

Description:

1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.

Treatment:

Drug: Cyclophosphamide

Drug: Carboplatin

Drug: Paclitaxel

Drug: Doxorubicin

B- BRCA Mutation

Active Comparator group

Description:

1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.

Treatment:

Drug: Cyclophosphamide

Drug: Paclitaxel

Drug: Doxorubicin

C- BRCA wild-type

Experimental group

Description:

1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.

Treatment:

Drug: Cyclophosphamide

Drug: Carboplatin

Drug: Paclitaxel

Drug: Doxorubicin

D- BRCA wild-type

Active Comparator group

Description:

1. Doxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: 2. Paclitaxel 80 mg/m2 once a week, for 12 weeks.

Treatment:

Drug: Cyclophosphamide

Drug: Paclitaxel

Drug: Doxorubicin