DCb (Docetaxel/Carboplatin) Versus EC-D (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer

NCT03154749 | Completed Phase 2

• 1 other identifier: 20170512
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Both DCb (docetaxel/carboplatin) and EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of DCb (docetaxel/carboplatin) and EC followed by D(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Conditions

Triple-Negative Breast Cancer

Keywords

Neoadjuvant chemotherapy; Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PCR

  Local evaluation of pCR defined as the absence of any residual invasive cancer of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/is, ypN0 in the current AJCC staging system)

  Up to approximately 27-30 weeks

Secondary Outcomes (4)

• Breast-conserving surgery rate

  Up to approximately 27-30 weeks

• EFS

  Up to approximately 36 months

• OS

  Up to approximately 36 months

• Adverse events

  Up to approximately 27-30 weeks

Other Outcomes (1)

• Candidate predictors of pCR

  Up to approximately 27-30 weeks

Study Arms (2)

DCb

EXPERIMENTAL

Docetaxel (75 mg/m2 administered intravenously every 3 weeks) and carboplatin (area under the concentration-time curve \[AUC\] 6, intravenously every 3 weeks) for six cycles

Drug: DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)

EC-D

ACTIVE COMPARATOR

Epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles

Drug: DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)

Interventions

DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) DRUG

All eligible patients were randomly assigned at a 1:1 ratio to the experimental arm (docetaxel (75 mg/m2 administered intravenously every 3 weeks) plus carboplatin (AUC 6 mg/mL per min, intravenously every 3 weeks) for six cycles) or the standard treatment arm (epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles).

DCb; EC-D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Stage IV (metastatic) breast cancer
• Patients with a history of invasive breast cancer.
• Patients with a history of ductal carcinoma in situ (DCIS), except for patients treated exclusively with mastectomy \> 5 years prior to diagnosis of current breast cancer
• Patients with bilateral breast cancer
• Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer.
• Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
• History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
• Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
• Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
• Current pregnancy and/or breastfeeding

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Shantou Central Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Henan Cancer Hospital: collaborator
• Dongguan People's Hospital: collaborator
• Baotou Cancer Hospital: collaborator

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (4)

• Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25.

  PMID: 38918556 DERIVED

• Yang C, Li P, Chen Y, Zheng J, Zhang X, Gao HF, Zhang L, Wang K. Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy. Support Care Cancer. 2024 Jun 3;32(6):401. doi: 10.1007/s00520-024-08610-3.

  PMID: 38829506 DERIVED

• Zhang L, Wu Z, Li J, Zhu D, Yang L, Shao Y, Lin Y, Liu Z, Cao Y, Zhang G, Shang S, Zhang Y, Wang K. Impact of Homologous Recombination Deficiency on Outcomes in Patients With Triple-Negative Breast Cancer Treated With Carboplatin-Based Neoadjuvant Chemotherapy: Secondary Analysis of the NeoCART Randomized Clinical Trial. JCO Precis Oncol. 2023 Jan;7:e2200337. doi: 10.1200/PO.22.00337.

  PMID: 36652665 DERIVED

• Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.

  PMID: 32657611 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Wang Kun, MD

  Study Chair

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: September 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

CN (1)