A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive, HER2-negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742051
• Other study ID #: 50102016015
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: March 14, 2020

Study information

• Verified date: September 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18 weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with ER-positive, HER2-negative breast cancer. Secondary aims are to compare the ultrasound response rate, pathological complete response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the percentages or counts of peripheral blood CD4+ T cells, CD8+ T cells, tumor-specific CTLs, T helper cells (Th), regulatory T cells (Treg), and NK cells and changes in tumor Ki67 index (pre- versus post- neoadjuvant therapy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The patients signed the written informed consent

• The patients present with non-metastatic unilateral invasive ER-positive, HER2-negative breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging.

• Postmenopausal women with age less than 70 years old.

• The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy.

• The patients have normal cardiac functions by echocardiography.

• The patients' ECOG scores are =2.

• The patients can swallow pills.

• The results of patients' blood tests are as follows:

• Hb=90g/L;

• WBC=4E+9/L;

• Plt=100E+9/L;

• Neutrophils=1.5E+9/L;

• ALT and AST = triple of normal upper limit;

• TBIL = 1.5 times of normal upper limit;

• Creatinine = 1.5 times of normal upper limit.

Exclusion Criteria:

• The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;

• The patients have active infections that were not suitable for chemotherapy;

• The patients have severe non-cancerous diseases.

• The patients have bilateral breast cancers or multifocal breast cancers or inflammatory breast cancers.

• The patients have a history of previous treatment with mTOR inhibitors.

• The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.

• The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.

• The patients have allergic history or contraindication of any of the interventional drugs.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Everolimus
Neoadjuvant endocrine therapy
• Letrozole
Neoadjuvant endocrine therapy
• Fluorouracil
Neoadjuvant chemotherapy
• Epirubicin
Neoadjuvant chemotherapy
• Cyclophosphamide
Neoadjuvant chemotherapy

Locations

Country	Name	City	State
China	Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the trial		during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)
Secondary	Ultrasound response rate		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Pathological complete response (pCR) rate		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Breast-conserving surgery rate		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)
Secondary	Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Peripheral blood NK cell percentage change in relation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Blood tumor-specific CTLs count change in relation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Peripheral blood CD4+ T cell percentage change in relation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)
Secondary	Tumor Ki67 index change in ralation to neoadjuvant therapy		at definitive surgery (18-20 weeks after the first dose of study medication)