Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

NCT01503905 | Unknown DMC

• 1 other identifier: BCSCO001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 17

Brief Summary

The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.

Conditions

Breast Cancer Nos Premenopausal

Keywords

breast cancer; neoadjuvant chemotherapy; amenorrhea

Outcome Measures

Primary Outcomes (2)

• Progression-free survival of patients.

  within 10 years after diagnosis

• Overall survival of the patients

  within 10 years after diagnosis

Secondary Outcomes (2)

• The pathological remission rate of patients after neoadjuvant chemotherapy.

  within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)

• The clinical remission rate of patients after neoadjuvant chemotherapy

  within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)

Study Arms (2)

Docetaxel plus epirubicin

ACTIVE COMPARATOR

Drug: Docetaxel; Drug: epirubicin; Procedure: Modified radical mastectomy or breast-conserving Surgery; Drug: Docetaxel (post-operative); Drug: Epirubicin (post-operative); Radiation: Radiation therapy; Drug: Herceptin （post-operative); Drug: Tamoxifen (post-operative)

docetaxel plus epirubicin plus cyclophosphamide

ACTIVE COMPARATOR

Drug: Docetaxel; Drug: epirubicin; Drug: cyclophosphamide; Procedure: Modified radical mastectomy or breast-conserving Surgery; Drug: Docetaxel (post-operative); Drug: Epirubicin (post-operative); Drug: Cyclophosphamide (post-operative); Radiation: Radiation therapy; Drug: Herceptin （post-operative); Drug: Tamoxifen (post-operative)

Interventions

Docetaxel DRUG

75mg/m2, iv injection, day1, every 21 days

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

epirubicin DRUG

80mg/ m2, iv injection, day1, every 21 days

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

cyclophosphamide DRUG

500 mg/m2, iv injection, day1, every 21 days

docetaxel plus epirubicin plus cyclophosphamide

Modified radical mastectomy or breast-conserving Surgery PROCEDURE

Two weeks after four cycles of neoadjuvant chemotherapy

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

Docetaxel (post-operative) DRUG

Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

Epirubicin (post-operative) DRUG

Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

Cyclophosphamide (post-operative) DRUG

Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.

docetaxel plus epirubicin plus cyclophosphamide

Radiation therapy RADIATION

Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

Herceptin （post-operative) DRUG

Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

Tamoxifen (post-operative) DRUG

After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.

Docetaxel plus epirubicin; docetaxel plus epirubicin plus cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients signed the written informed consent.
• The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
• The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
• The patients have normal cardiac functions by echocardiography.
• The patients' ECOG scores are ≤ 0-2.
• The age of patient is ≥ 18 years old; And the patients are premenopausal females.
• The patients are disposed to practice contraception during the whole trial.
• The results of patients' blood tests are as follows:
• Hb ≥ 90 g/L
• WBC ≥ 4.0×109/L
• Plt ≥ 100×109/L
• Neutrophils ≥ 1.5×109/L
• ALT and AST ≤ triple of normal upper limit.
• TBIL ≤ 1.5 times of normal upper limit.
• Creatinine ≤ 1.25 times of normal upper limit.

You may not qualify if:

• The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
• The patients have active infections that were not suitable for chemotherapy.
• The patients have severe non-cancerous diseases.
• The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
• The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
• The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
• The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
• The patients have allergic history of the chemotherapeutic agents.
• The patients have bilateral breast cancers.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (17)

The first People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

Guangdong Women and Children Hospital

Guangzhou, Guangdong, 510010, China

RECRUITING

Guangzhou Army General Hospital

Guangzhou, Guangdong, 510010, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Tumor Hospital of Guangzhou

Guangzhou, Guangdong, 510095, China

RECRUITING

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, 510100, China

RECRUITING

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Guangzhou Women and Children Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

The first People's Hospital of Guangzhou

Guangzhou, Guangdong, 510180, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Zhujiang Hospital of Nanfang Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Nanfang Hospital of Nanfang Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

The first Affiliated Hospital of Shenzhen University

Shenzhen, Guangdong, 518035, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Amenorrhea

Interventions

Docetaxel; Epirubicin; Cyclophosphamide; Mastectomy, Modified Radical; Mastectomy, Segmental; Postoperative Period; Radiotherapy; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Mastectomy, Radical; Mastectomy; Surgical Procedures, Operative; Perioperative Period; Patient Care; Health Services; Health Care Facilities Workforce and Services; Therapeutics; Stilbenes; Benzylidene Compounds; Benzene Derivatives

Study Officials

• Fengxi Su, M.D.

  Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Fengxi Su, M.D.

CONTACT

86-20-34071156; fengxisu@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Breast Tumor Centre

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 4, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2021
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

CN (17)