Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer
1 other identifier
interventional
290
1 country
1
Brief Summary
Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Nov 2017
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
November 29, 2017
CompletedFirst Submitted
Initial submission to the registry
April 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2020
CompletedApril 25, 2018
March 1, 2018
2 years
April 15, 2018
April 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
objective response rate
objective response rate (ORR) measured by breast ultrasound monthly
6 month
Study Arms (2)
Letrozole Plus Low-Dose Metronomic Capecitabine
EXPERIMENTALEC-T
ACTIVE COMPARATORInterventions
Letrozole Plus Low-Dose Metronomic Capecitabine
Eligibility Criteria
You may qualify if:
- women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC count, 3.5 \*109/L; platelets, 100\*109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal function (serum creatinine 1.25 the upper limit of normal value).
- Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients
You may not qualify if:
- (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis; (c) patients who were previously treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; (d) patients with a second concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Related Publications (1)
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: 32657611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2018
First Posted
April 25, 2018
Study Start
November 29, 2017
Primary Completion
November 29, 2019
Study Completion
November 29, 2020
Last Updated
April 25, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share