Status:
UNKNOWN
Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Cancer Nos Premenopausal
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01503905
Start Date
December 1 2011
End Date
December 1 2021
Last Update
May 24 2016
Active Locations (17)
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1
The first People's Hospital of Foshan
Foshan, Guangdong, China, 528000
2
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China, 510010
3
Guangzhou Army General Hospital
Guangzhou, Guangdong, China, 510010
4
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060