The Trial Comparing Dose-dense AC-T With TP as Adjuvant Therapy for TNBC With Homologous Recombination Repair Deficiency
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|ClinicalTrials.gov Identifier: NCT03876886|
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Epirubicin Drug: Cyclophosphamide Drug: Paclitaxel Drug: Carboplatin||Phase 3|
Triple-negative breast cancer (TNBC) lack the expression of oestrogen receptor (ER), progesterone receptor(PR) and human epidermal growth factor receptor 2 (HER2) , and characterizes an aggressive behavior with higher risk of recurrence and death compared to other breast cancer subtypes. Little therapeutic progress has been made in adjuvant therapy in TNBC during the past decades and the standard of care is still missing.
Pre-clinical and clinical data suggest that platinum-based regimens represent an emerging therapeutic option for selected patients with homologous recombination repair deficiency (HRD). The HR system is critical in regulating and maintaining genome stability, and is one of the most commonly altered systems in TNBCs, up to 15-20% TNBC patients carry germline BRCA1/2 mutations. Other HR genes included PALB2, RAD51 etc. Tumors that harbor HRD possess an increased burden of genomic aberrations and lesions, and have been shown to have increased sensitivity to DNA crosslinking agents such as platinum salts. Platinum-based regimens have been encouraging in TNBC patients with HRD, given increases in both pathologic complete response (pCR) rates in neoadjuvant trials and objective response rates(ORR) in metastatic diseases. Further information are needed on how platinum-containing therapies affect long-term outcomes in the adjuvant setting.
In this trial, the investigators intend to compare the 3-year disease-free survival (DFS) of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy in high-risk node-negative or node-positive TNBC patients with HRD. The other purpose of this trial is to observe the participants' tolerance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 22, 2019|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||December 2024|
Active Comparator: AC-T(dose-dense)
A: epirubicin, pharmorubicin (EPI) C: cyclophosphamide (CTX） T: paclitaxel (PTX）
Epirubicin 90mg/m2 iv d1 or divide into two days
cyclophosphamide600mg/m2 iv d1,q14d*4cycles;with G-CSF support: 3ug/kg ih
paclitaxel 175mg/m2 iv d1, q14d*4cycles
T: paclitaxel (PTX） P: carboplatin (CBP)
carboplatin AUC=3 iv d2, q14d*8cycles;with G-CSF support: 3ug/kg ih
paclitaxel 175mg/m2 iv d1, q14d*8cycles
- 3-year disease-free survival [ Time Frame: Three years ]The participants will be followed by the telephone for the duration, an expected average of 3 years.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Three years ]Incidence of neutropenic fever; Incidence of grade 3-4 side effects; Toxicity assessed by NCI CTCAE v5.0
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): NCT03876886
|Contact: Binghe Xuemail@example.com|
|Contact: Qing Lifirstname.lastname@example.org|
|National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Binghe XU, M.D. 86-10-88788826 email@example.com|