Neoadjuvant Carboplatin in Triple Negative Breast Cancer

December 25, 2022 updated by: Cristiano de Padua, Barretos Cancer Hospital

Neoadjuvant Carboplatin in Triple Negative Breast Cancer - A Prospective Phase II Study (NACATRINE Trial).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Barretos Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A- BRCA Mutation
  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.
Drug: Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Drug: Carboplatin
Carboplatin AUC 1,5 once a week, for 12 weeks
Drug: Paclitaxel
80mg/m2 weekly for 12 weeks
Drug: Cyclophosphamide
600mg/m2 4 cycles each 21 days
Active Comparator: B- BRCA Mutation
  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.
Drug: Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Drug: Paclitaxel
80mg/m2 weekly for 12 weeks
Drug: Cyclophosphamide
600mg/m2 4 cycles each 21 days
Experimental: C- BRCA wild-type
  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.
Drug: Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Drug: Carboplatin
Carboplatin AUC 1,5 once a week, for 12 weeks
Drug: Paclitaxel
80mg/m2 weekly for 12 weeks
Drug: Cyclophosphamide
600mg/m2 4 cycles each 21 days
Active Comparator: D- BRCA wild-type
  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.
Drug: Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Drug: Paclitaxel
80mg/m2 weekly for 12 weeks
Drug: Cyclophosphamide
600mg/m2 4 cycles each 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within the first 21 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2017

Primary Completion (Actual)

December 2, 2019

Study Completion (Actual)

October 22, 2021

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 25, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarretosCH - 20162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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