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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2020-11-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Letrozole Plus Low-Dose Metronomic Capecitabine

Group Type EXPERIMENTAL

Letrozole Plus Low-Dose Metronomic Capecitabine

Intervention Type DRUG

Letrozole Plus Low-Dose Metronomic Capecitabine

EC-T

Group Type ACTIVE_COMPARATOR

EC-T

Intervention Type DRUG

Epirubicin/Cyclophosphamide Followed by Docetaxel

Interventions

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Letrozole Plus Low-Dose Metronomic Capecitabine

Intervention Type DRUG

EC-T

Epirubicin/Cyclophosphamide Followed by Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No