The Trial Comparing Dose-dense AC-T With TP as Adjuvant Therapy for TNBC With Homologous Recombination Repair Deficiency
Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer With Homologous Recombination Repair Deficiency
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this trial is to compare the 3-year disease-free survival of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer with homologous recombination repair deficiency. The other purpose of this trial is to observe the patient's tolerance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2019
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2019
CompletedFirst Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 21, 2019
March 1, 2019
4.9 years
March 14, 2019
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease-free survival
The participants will be followed by the telephone for the duration, an expected average of 3 years.
Three years
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Three years
Study Arms (2)
AC-T(dose-dense)
ACTIVE COMPARATORA: epirubicin, pharmorubicin (EPI) C: cyclophosphamide (CTX） T: paclitaxel (PTX）
TP(dose-dense)
EXPERIMENTALT: paclitaxel (PTX） P: carboplatin (CBP)
Interventions
cyclophosphamide600mg/m2 iv d1,q14d\*4cycles;with G-CSF support: 3ug/kg ih
Eligibility Criteria
You may qualify if:
- years
- Histologically confirmed adenocarcinoma of the breast, complete tumor removal by either modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed);
- Histologically confirmed ER(-) PR(-) and HER-2(IHC(immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative)
- Next-generation sequencing confirmed homologous recombination repair deficiency
- Meet one of the following criteria:
- (1) Positive axillary lymph nodes; (2) Negative axillary lymph nodes with at least one of the following risk factors: age\<= 35 years; grade III; infiltrative tumor size \> 2cm; intravascular tumor embolus; Ki-67\>=50%.
- \. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1 7. Adequate bone marrow reserve with ANC \> 1500, HGB \> 9g/dL and platelets \> 100,000.
- \. Adequate renal function with serum creatinine \< 2.0. 9. Adequate hepatic reserve with serum bilirubin \< 2.0, AST/ALT \< 2X the upper limit of normal, and alkaline phosphatase \< 5X the upper limit of normal. Serum bilirubin \> 2.0 is acceptable in the setting of known Gilbert's syndrome.
- \. Not pregnant, and on appropriate birth control if of child-bearing potential.
- \. Written informed consent according to the local ethics committee requirements.
You may not qualify if:
- Prior systemic treatment of breast cancer, including chemotherapy;
- Metastatic breast cancer;
- Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
- Contraindication for using dexamethasone;
- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP\>180 mmHg or diastolic BP\>100 mmHg);
- Pregnant or breast feeding.
- Hepatic, renal, or bone marrow dysfunction as detailed above.
- Known severe hypersensitivity to any drugs in this study;
- Treatment with any investigational drugs within 30 days before the beginning of study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medical Oncology
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 15, 2019
Study Start
February 22, 2019
Primary Completion
February 1, 2024
Study Completion
December 1, 2024
Last Updated
March 21, 2019
Record last verified: 2019-03