Actively Recruiting
Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2022-04-27
688
Participants Needed
17
Research Sites
626 weeks
Total Duration
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AI-Summary
What this Trial Is About
The current study is a multicentre, randomized,double-blind, prospective clinical trial stratified patients by the HER2 status of their cancer (negative or positive) which is sponsored by the researchers. The trial is designed to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer patients. 688 female ER(ER-α)/PR negative, ER-β(wild type ER-β1) positive operable breast cancer patients who had undergone neoadjuvant chemotherapy or directly modified radical mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive tamoxifen (20 mg per day) or placebo (2# per day) within 6 weeks after postoperative chemotherapy and/or radiation therapy if needed (according to 2013 NCCN breast cancer guideline). If the breast tumor's HER2 is positive, the patient can receive targeted therapy (Herceptin) combined with tamoxifen or placebo. The follow-up time will be eight years. The aim of this trial is to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer patients by comparing the DFS and OS between tamoxifen group and placebo group and to determine whether the percentage of positive ER-β expression is associated with the response to the hormone therapy in breast cancer.
CONDITIONS
Official Title
Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Operable unilateral invasive breast cancer without distant metastasis (stage I, II, III)
- Tumor ER/PR positive rate less than 1%, ER-beta1 positive rate at least 10% by immunohistochemistry
- No history of neoadjuvant hormone therapy
- Normal cardiac function confirmed by echocardiography
- ECOG performance status score of 0 to 2
- Non-pregnant and willing to use contraception throughout the trial
- Underwent neoadjuvant chemotherapy plus surgery or direct modified radical mastectomy or breast-conserving surgery with lymph node assessment
- Received chemotherapy, radiation, or targeted therapy (Herceptin) after surgery as per 2013 NCCN guidelines
- Blood test results within specified limits: Hemoglobin ≥ 90g/L, WBC ≥ 4.0×10⁹/L, Platelets ≥ 100×10⁹/L, Neutrophils ≥ 1.5×10⁹/L, liver enzymes and bilirubin not exceeding specified upper limits, creatinine ≤ 1.25 times upper limit
You will not qualify if you...
- Having other active cancers or history of other cancers except controlled skin basal cell carcinoma, skin squamous cell carcinoma, or carcinoma in situ of cervix
- Active infections unsuitable for chemotherapy
- Severe non-cancerous diseases
- History of neoadjuvant hormone therapy
- Bilateral breast cancers, ductal carcinoma in situ (DCIS), or metastatic breast cancers
- Currently receiving anti-cancer therapies or participating in other clinical trials
- Pregnant, lactating, or refusing contraception during the trial
- Unable to understand informed consent due to conditions like dementia
- History of allergy or contraindication to tamoxifen
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Trial Site Locations
Total: 17 locations
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China, 510010
Actively Recruiting
4
Guangzhou Army General Hospital
Guangzhou, Guangdong, China, 510010
Actively Recruiting
5
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
6
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
7
Guangzhou Women and Children Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
8
The third people's Hospital of Huizhou
Huizhou, Guangdong, China, 516000
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9
Xinjiang Medical School Cancer Center
Xinjiang, Xinjiang, China
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10
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
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11
Dongguan People's Hospital
Dongguan, China
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12
Foshan First People's Hospital
Foshan, China
Actively Recruiting
13
The sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Actively Recruiting
14
Zhejiang Provincial People's Hospital
Hangzhou, China
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15
Lian Jiang People's Hospital
Lianjiang, China
Actively Recruiting
16
The Third Hospital of Nanchang
Nanchang, China
Actively Recruiting
17
The Second People's Hospital of Shenzhen
Shenzhen, China
Actively Recruiting
Research Team
E
Erwei Song, M.D., Ph. D.
CONTACT
Q
Qiang Liu, M.D., Ph. D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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