Neoadjuvant Carboplatin in Triple Negative Breast Cancer

Sponsor

Barretos Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02978495

Collaborator

(none)

120

Enrollment

Location

Arms

66.5

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
BRCA1 Hereditary Breast and Ovarian Cancer Syndrome	Drug: Doxorubicin Drug: Carboplatin Drug: Paclitaxel Drug: Cyclophosphamide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 17, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A- BRCA Mutation Doxorrubicin 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.	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 Doxorrubicin 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.	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 Doxorrubicin 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.	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 Doxorrubicin 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.	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Disease free survival (DFS) [within the first 60 month after surgery]
Overall survival (OS) [within the first 60 month after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barretos Cancer Hospital	Barretos	SP	Brazil	14784-400

Sponsors and Collaborators

Barretos Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cristiano de Pádua Souza, MD, PhD, Principal Investigator, Barretos Cancer Hospital

ClinicalTrials.gov Identifier:

NCT02978495

Other Study ID Numbers:

BarretosCH - 20162

First Posted:

Dec 1, 2016

Last Update Posted:

Jul 16, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Triple Negative Breast Neoplasms

Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of Jul 16, 2019