Clinical trial NCT01503905: Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Nos Premenopausal
Keywords: breast cancer
neoadjuvant chemotherapy
amenorrhea
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival of patients.
timeFrame: within 10 years after diagnosis
measure: Overall survival of the patients
timeFrame: within 10 years after diagnosis
Secondary outcomes:
measure: The pathological remission rate of patients after neoadjuvant chemotherapy.
timeFrame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
measure: The clinical remission rate of patients after neoadjuvant chemotherapy
timeFrame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
Other outcomes:
Locations:
city: Foshan
country: China
facility: The first People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Women and Children Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Army General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Tumor Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The first People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Nanfang Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Nanfang Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The first Affiliated Hospital of Shenzhen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
name: Fengxi Su, M.D.
role: STUDY_CHAIR
References: