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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507465
• Other study ID #: Guangdong General Hospital
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 15, 2018
• Last updated: April 24, 2018
• Start date: November 29, 2017
• Est. completion date: November 29, 2020

Study information

• Verified date: March 2018
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: November 29, 2020
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole Plus Low-Dose Metronomic Capecitabine
Letrozole Plus Low-Dose Metronomic Capecitabine
• EC-T
Epirubicin/Cyclophosphamide Followed by Docetaxel

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	objective response rate (ORR) measured by breast ultrasound monthly	6 month