Back to resultsA Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Everolimus
Letrozole
Fluorouracil
Epirubicin
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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.
Sites / Locations
- Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Everolimus+Letrozole
Fluorouracil+epirubicin+cyclophosphamide
Arm Description
everolimus 10mg/d,po + letrozole 2.5mg/d,po * 18 weeks
Fluorouracil 600mg/m2,iv,d1 + epirubicin 90mg/m2,iv,d1 + cyclophosphamide 600mg/m2,iv,d1 * 6 cycles (every 21 days per cycle)
Outcomes
Primary Outcome Measures
Feasibility of the trial
Secondary Outcome Measures
Ultrasound response rate
Pathological complete response (pCR) rate
Breast-conserving surgery rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy
Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy
Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy
Peripheral blood NK cell percentage change in relation to neoadjuvant therapy
Blood tumor-specific CTLs count change in relation to neoadjuvant therapy
Peripheral blood CD4+ T cell percentage change in relation to neoadjuvant therapy
Tumor Ki67 index change in ralation to neoadjuvant therapy
Full Information
NCT ID
NCT02742051
First Posted
April 7, 2016
Last Updated
September 22, 2021
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02742051
Brief Title
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
Official Title
A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive, HER2-negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
March 14, 2020 (Actual)
Study Completion Date
March 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Everolimus+Letrozole
Arm Type
Experimental
Arm Description
everolimus 10mg/d,po + letrozole 2.5mg/d,po * 18 weeks
Arm Title
Fluorouracil+epirubicin+cyclophosphamide
Arm Type
Active Comparator
Arm Description
Fluorouracil 600mg/m2,iv,d1 + epirubicin 90mg/m2,iv,d1 + cyclophosphamide 600mg/m2,iv,d1 * 6 cycles (every 21 days per cycle)
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
RAD001
Intervention Description
Neoadjuvant endocrine therapy
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Neoadjuvant endocrine therapy
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-Fu
Intervention Description
Neoadjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
EPB
Intervention Description
Neoadjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
CTX
Intervention Description
Neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
Feasibility of the trial
Time Frame
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 Outcome Measure Information:
Title
Ultrasound response rate
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Pathological complete response (pCR) rate
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Breast-conserving surgery rate
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)
Title
Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Peripheral blood NK cell percentage change in relation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Blood tumor-specific CTLs count change in relation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Peripheral blood CD4+ T cell percentage change in relation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
Title
Tumor Ki67 index change in ralation to neoadjuvant therapy
Time Frame
at definitive surgery (18-20 weeks after the first dose of study medication)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieqiong Liu, M.D.,Ph.D.
Organizational Affiliation
Breast Tumor Center, Sun Yat-sen Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34315439
Citation
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.
Results Reference
derived
PubMed Identifier
29070044
Citation
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.
Results Reference
derived
Learn more about this trial
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
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