Clinical Trials /

Neoadjuvant Carboplatin in Triple Negative Breast Cancer

NCT02978495

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Carboplatin in Triple Negative Breast Cancer
  • Official Title: Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).

Clinical Trial IDs

  • ORG STUDY ID: BarretosCH - 20162
  • NCT ID: NCT02978495

Conditions

  • BRCA1 Hereditary Breast and Ovarian Cancer Syndrome

Interventions

DrugSynonymsArms
DoxorubicinA- BRCA Mutation
CarboplatinA- BRCA Mutation
PaclitaxelA- BRCA Mutation
CyclophosphamideA- BRCA Mutation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
A- BRCA MutationExperimentalDoxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
  • Doxorubicin
  • Carboplatin
  • Paclitaxel
  • Cyclophosphamide
B- BRCA MutationActive ComparatorDoxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: Paclitaxel 80 mg/m2 once a week, for 12 weeks.
  • Doxorubicin
  • Paclitaxel
  • Cyclophosphamide
C- BRCA wild-typeExperimentalDoxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: Paclitaxel 80 mg/m2 once a week, for 12 weeks, concomitant to Carboplatin AUC 1,5 once a week, for 12 weeks.
  • Doxorubicin
  • Carboplatin
  • Paclitaxel
  • Cyclophosphamide
D- BRCA wild-typeActive ComparatorDoxorrubicin 60 mg/m2 concomitantly with Cyclophosphamide 600mg/m2, every 3 weeks, for 4 cycles followed by: Paclitaxel 80 mg/m2 once a week, for 12 weeks.
  • Doxorubicin
  • Paclitaxel
  • Cyclophosphamide

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:Pathological complete response (pCR), defined as absence of invasive cancer in the breast and axillary lymph nodes.
Time Frame:within the first 21 days after surgery
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Disease free survival (DFS)
Time Frame:within the first 60 month after surgery
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:within the first 60 month after surgery
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Barretos Cancer Hospital

Last Updated