Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

Breast Cancer Nos Premenopausal Clinical Trial

Official title:

Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01503905
• Other study ID #: BCSCO001
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2011
• Last updated: May 23, 2016
• Start date: December 2011
• Est. completion date: December 2021

Study information

• Verified date: May 2016
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Fengxi Su, M.D.
• Phone: 86-20-34071156
• Email: fengxisu[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patients signed the written informed consent.

2. The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.

3. The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.

4. The patients have normal cardiac functions by echocardiography.

5. The patients' ECOG scores are = 0-2.

6. The age of patient is = 18 years old; And the patients are premenopausal females.

7. The patients are disposed to practice contraception during the whole trial.

8. 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.

Exclusion Criteria:

1. 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.

2. The patients have active infections that were not suitable for chemotherapy.

3. The patients have severe non-cancerous diseases.

4. The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.

5. The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.

6. The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.

7. The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.

8. The patients have allergic history of the chemotherapeutic agents.

9. The patients have bilateral breast cancers.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer Nos Premenopausal
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
75mg/m2, iv injection, day1, every 21 days
• epirubicin
80mg/ m2, iv injection, day1, every 21 days
• cyclophosphamide
500 mg/m2, iv injection, day1, every 21 days

Procedure:
• Modified radical mastectomy or breast-conserving Surgery
Two weeks after four cycles of neoadjuvant chemotherapy

Drug:
• Docetaxel (post-operative)
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
• Epirubicin (post-operative)
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
• Cyclophosphamide (post-operative)
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.

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

Drug:
• Herceptin (post-operative)
Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
• Tamoxifen (post-operative)
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.

Locations

Country	Name	City	State
China	The first People's Hospital of Foshan	Foshan	Guangdong
China	Guangdong Women and Children Hospital	Guangzhou	Guangdong
China	Guangzhou Army General Hospital	Guangzhou	Guangdong
China	Guangzhou Women and Children Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Nanfang Medical University	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The first People's Hospital of Guangzhou	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Tumor Hospital of Guangzhou	Guangzhou	Guangdong
China	Zhujiang Hospital of Nanfang Medical University	Guangzhou	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The first Affiliated Hospital of Shenzhen University	Shenzhen	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	Progression-free survival of patients.		within 10 years after diagnosis	No
Primary	Overall survival of the patients		within 10 years after diagnosis	No
Secondary	The pathological remission rate of patients after neoadjuvant chemotherapy.		within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)	No
Secondary	The clinical remission rate of patients after neoadjuvant chemotherapy		within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)	No