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

NCT ID: NCT02742051

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-03-14

Brief 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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus+Letrozole

everolimus 10mg/d,po + letrozole 2.5mg/d,po \* 18 weeks

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Neoadjuvant endocrine therapy

Letrozole

Intervention Type: DRUG

Neoadjuvant endocrine therapy

Fluorouracil+epirubicin+cyclophosphamide

Fluorouracil 600mg/m2,iv,d1 + epirubicin 90mg/m2,iv,d1 + cyclophosphamide 600mg/m2,iv,d1 \* 6 cycles (every 21 days per cycle)

Group Type: ACTIVE_COMPARATOR

Fluorouracil

Intervention Type: DRUG

Neoadjuvant chemotherapy

Epirubicin

Intervention Type: DRUG

Neoadjuvant chemotherapy

Cyclophosphamide

Intervention Type: DRUG

Neoadjuvant chemotherapy

Interventions

Everolimus

Neoadjuvant endocrine therapy

Intervention Type: DRUG

Letrozole

Neoadjuvant endocrine therapy

Intervention Type: DRUG

Fluorouracil

Neoadjuvant chemotherapy

Intervention Type: DRUG

Epirubicin

Neoadjuvant chemotherapy

Intervention Type: DRUG

Cyclophosphamide

Neoadjuvant chemotherapy

Intervention Type: DRUG

Other Intervention Names

RAD001; Femara; 5-Fu; EPB; CTX

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Jieqiong Liu, M.D., Ph.D.

Attending Surgeon of Breast Tumor Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jieqiong Liu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Breast Tumor Center, Sun Yat-sen Memorial Hospital

Locations

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

References

Wu W, Chen J, Deng H, Jin L, He Z, Rao N, Nie Y, Yao Y, Yang Y, Su F, Liu J. Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: a randomized pilot trial. BMC Cancer. 2021 Jul 27;21(1):862. doi: 10.1186/s12885-021-08612-y.

Reference Type: DERIVED

PMID: 34315439 (View on PubMed)

Wu W, Deng H, Rao N, You N, Yang Y, Cao M, Liu J. Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: study protocol for a randomized pilot trial. Trials. 2017 Oct 25;18(1):497. doi: 10.1186/s13063-017-2228-5.

Reference Type: DERIVED

PMID: 29070044 (View on PubMed)

Other Identifiers

50102016015

Identifier Type: -

Identifier Source: org_study_id