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

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ClinicalTrials.gov Identifier: NCT02742051
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jieqiong Liu, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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, and to compare the objective response rate. Secondary aims are to compare the response rate by clinical palpation, pathological complete response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the percentages of peripheral blood CD8+ T cells, T helper cells (Th), regulatory T cells (Treg), and NK cells (pre- versus post- neoadjuvant therapy).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Everolimus Drug: Letrozole Drug: Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive, HER2-negative Breast Cancer
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Everolimus+Letrozole
everolimus 10mg/d,po + letrozole 2.5mg/d,po * 18 weeks
Drug: Everolimus
Neoadjuvant endocrine therapy
Other Name: RAD001

Drug: Letrozole
Neoadjuvant endocrine therapy
Other Name: Femara

Active Comparator: 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)
Drug: Fluorouracil
Neoadjuvant chemotherapy
Other Name: 5-Fu

Drug: Epirubicin
Neoadjuvant chemotherapy
Other Name: EPB

Drug: Cyclophosphamide
Neoadjuvant chemotherapy
Other Name: CTX




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: at definitive surgery (18-20 weeks after the first dose of study medication) ]

Secondary Outcome Measures :
  1. Response rate by clinical palpation [ Time Frame: at definitive surgery (18-20 weeks after the first dose of study medication) ]
  2. Pathological complete response (pCR) rate [ Time Frame: at definitive surgery (18-20 weeks after the first dose of study medication) ]
  3. Breast-conserving surgery rate [ Time Frame: at definitive surgery (18-20 weeks after the first dose of study medication) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742051


Contacts
Contact: Jieqiong Liu, M.D.,Ph.D. 8620-81332576 liujieqiong01@163.com
Contact: Qiang Liu, M.D.,Ph.D. victorlq@hotmail.com

Locations
China, Guangdong
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jieqiong Liu, M.D.,Ph.D.    8620-81332576    liujieqiong01@163.com   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Principal Investigator: Jieqiong Liu, M.D.,Ph.D. Breast Tumor Center, Sun Yat-sen Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jieqiong Liu, M.D., Ph.D., Attending Surgeon of Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02742051     History of Changes
Other Study ID Numbers: 50102016015
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Everolimus
Sirolimus
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Letrozole
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists