Neoadjuvant Carboplatin in Triple Negative Breast Cancer
NCT ID: NCT02978495
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2017-05-17
2021-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Carboplatin
Carboplatin AUC 1,5 once a week, for 12 weeks
Paclitaxel
80mg/m2 weekly for 12 weeks
Cyclophosphamide
600mg/m2 4 cycles each 21 days
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.
Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Paclitaxel
80mg/m2 weekly for 12 weeks
Cyclophosphamide
600mg/m2 4 cycles each 21 days
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.
Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Carboplatin
Carboplatin AUC 1,5 once a week, for 12 weeks
Paclitaxel
80mg/m2 weekly for 12 weeks
Cyclophosphamide
600mg/m2 4 cycles each 21 days
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.
Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Paclitaxel
80mg/m2 weekly for 12 weeks
Cyclophosphamide
600mg/m2 4 cycles each 21 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Doxorubicin
Doxorrubicin 60 mg/m2 4 cycles each 21 days
Carboplatin
Carboplatin AUC 1,5 once a week, for 12 weeks
Paclitaxel
80mg/m2 weekly for 12 weeks
Cyclophosphamide
600mg/m2 4 cycles each 21 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* other malignancies.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Barretos Cancer Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cristiano de Padua
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
Gerber B, Loibl S, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Nekljudova V, Untch M, von Minckwitz G; German Breast Group Investigators. Neoadjuvant bevacizumab and anthracycline-taxane-based chemotherapy in 678 triple-negative primary breast cancers; results from the geparquinto study (GBG 44). Ann Oncol. 2013 Dec;24(12):2978-84. doi: 10.1093/annonc/mdt361. Epub 2013 Oct 17.
Byrski T, Gronwald J, Huzarski T, Grzybowska E, Budryk M, Stawicka M, Mierzwa T, Szwiec M, Wisniowski R, Siolek M, Dent R, Lubinski J, Narod S. Pathologic complete response rates in young women with BRCA1-positive breast cancers after neoadjuvant chemotherapy. J Clin Oncol. 2010 Jan 20;28(3):375-9. doi: 10.1200/JCO.2008.20.7019. Epub 2009 Dec 14.
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
Valsecchi ME, Kimmey G, Bir A, Silbermins D. Role of Carboplatin in the Treatment of Triple Negative Early- Stage Breast Cancer. Rev Recent Clin Trials. 2015;10(2):101-10. doi: 10.2174/1574887110666150624101343.
Arun B, Bayraktar S, Liu DD, Gutierrez Barrera AM, Atchley D, Pusztai L, Litton JK, Valero V, Meric-Bernstam F, Hortobagyi GN, Albarracin C. Response to neoadjuvant systemic therapy for breast cancer in BRCA mutation carriers and noncarriers: a single-institution experience. J Clin Oncol. 2011 Oct 1;29(28):3739-46. doi: 10.1200/JCO.2011.35.2682. Epub 2011 Sep 6.
Gonzalez-Angulo AM, Timms KM, Liu S, Chen H, Litton JK, Potter J, Lanchbury JS, Stemke-Hale K, Hennessy BT, Arun BK, Hortobagyi GN, Do KA, Mills GB, Meric-Bernstam F. Incidence and outcome of BRCA mutations in unselected patients with triple receptor-negative breast cancer. Clin Cancer Res. 2011 Mar 1;17(5):1082-9. doi: 10.1158/1078-0432.CCR-10-2560. Epub 2011 Jan 13.
Paluch-Shimon S, Friedman E, Berger R, Papa M, Dadiani M, Friedman N, Shabtai M, Zippel D, Gutman M, Golan T, Yosepovich A, Catane R, Modiano T, Kaufman B. Neo-adjuvant doxorubicin and cyclophosphamide followed by paclitaxel in triple-negative breast cancer among BRCA1 mutation carriers and non-carriers. Breast Cancer Res Treat. 2016 May;157(1):157-65. doi: 10.1007/s10549-016-3800-5. Epub 2016 Apr 25.
Muendlein A, Rohde BH, Gasser K, Haid A, Rauch S, Kinz E, Drexel H, Hofmann W, Schindler V, Kapoor R, Decker T, Lang AH. Evaluation of BRCA1/2 mutational status among German and Austrian women with triple-negative breast cancer. J Cancer Res Clin Oncol. 2015 Nov;141(11):2005-12. doi: 10.1007/s00432-015-1986-2. Epub 2015 May 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BarretosCH - 20162
Identifier Type: -
Identifier Source: org_study_id