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Neoadjuvant Carboplatin in Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT02978495
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Cristiano de Pádua Souza, MD, PhD, Barretos Cancer Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022


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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: within the first 60 month after surgery ]
  2. Overall survival (OS) [ Time Frame: within the first 60 month after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978495


Contacts
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Contact: Cristiano P Souza, MD +55 17 33216600 ext 7128 crispadua10@gmail.com

Locations
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Brazil
Barretos Cancer Hospital Recruiting
Barretos, SP, Brazil, 14784-400
Sponsors and Collaborators
Barretos Cancer Hospital

Publications of Results:

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Responsible Party: Cristiano de Pádua Souza, MD, PhD, Principal Investigator, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02978495     History of Changes
Other Study ID Numbers: BarretosCH - 20162
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents