Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: EC-T; Drug: Letrozole Plus Low-Dose Metronomic Capecitabine

• Registration Number: NCT03507465
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-29
• Status Verified: 2018-03
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-24
• Last Update Submitted: 2018-04-24
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25
• Primary Completion: 2019-11-29
• Study Completion: 2020-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

-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

Exclusion Criteria

• (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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EC-T	EC-T	-
Letrozole Plus Low-Dose Metronomic Capecitabine	Letrozole Plus Low-Dose Metronomic Capecitabine	-

Primary Outcome Measures

Name	Time	Method
objective response rate	6 month	objective response rate (ORR) measured by breast ultrasound monthly

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China