Evaluating tamoxifen for specific breast cancer patients

Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients

This study is testing if tamoxifen can help women with a specific type of breast cancer feel better after their surgery or chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 688 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 17 sites (Guangzhou, Guangdong and 16 other locations)
• Trial ID: NCT02062489 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind clinical trial aims to assess the effectiveness of tamoxifen as an adjuvant therapy for operable breast cancer patients who are ER/PR negative and ER-beta positive. A total of 688 female participants, aged 18 to 70, will be enrolled after undergoing neoadjuvant chemotherapy or surgery. They will be randomly assigned to receive either tamoxifen or a placebo for eight years, with follow-up assessments to evaluate treatment outcomes. The trial also considers HER2 status, allowing for targeted therapy if necessary.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 70 with operable unilateral invasive breast cancer that is ER/PR negative and ER-beta positive.

Not a fit: Patients with distant metastasis or those who have previously received neoadjuvant hormone therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with a specific subtype of breast cancer, potentially improving their outcomes.

How similar studies have performed: Other studies have explored tamoxifen's efficacy in breast cancer, but this specific approach targeting ER-beta positive patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

* The patients signed the written informed consent
* The patients present with operable unilateral invasive breast cancers without distant metastasis(stage I, II, and III)
* The breast tumor's positive ER/PR rate is \<1%, and positive ER-beta1 rate is ≥10% by IHC.
* The patients have no history of neoadjuvant hormone therapy.
* The patients have normal cardiac functions by echocardiography.
* The patients' ECOG scores are ≤0-2.
* Female patient who is ≥ 18yrs, and ≤ 70yrs.
* The patients are non-pregnant, and disposed to practice contraception during the whole trial.
* The patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer.
* The patients underwent chemotherapy, radiation therapy or targeted therapy(herceptin) after surgery according to the 2013 NCCN guideline.
* The results of patients' blood tests are as follows:

Hb≥90g/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:

* The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
* The patients have active infections that were not suitable for chemotherapy;
* The patients have severe non-cancerous diseases.
* The patients have history of neoadjuvant hormone therapy.
* The patients have bilateral breast cancers or DCIS or metastatic breast cancers.
* The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
* 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 or contraindication of tamoxifen.

Where this trial is running

Guangzhou, Guangdong and 16 other locations

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Guangdong Women and Children Hospital — Guangzhou, Guangdong, China (Recruiting)
• Guangzhou Army General Hospital — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
• Guangzhou Women and Children Hospital — Guangzhou, Guangdong, China (Recruiting)
• The third people's Hospital of Huizhou — Huizhou, Guangdong, China (Recruiting)
• Xinjiang Medical School Cancer Center — Xinjiang, Xinjiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Dongguan People's Hospital — Dongguan, China (Recruiting)
• Foshan First People's Hospital — Foshan, China (Recruiting)
• The sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Recruiting)
• Lian Jiang People's Hospital — Lianjiang, China (Recruiting)
• The Third Hospital of Nanchang — Nanchang, China (Recruiting)
• The Second People's Hospital of Shenzhen — Shenzhen, China (Recruiting)

Study contacts

• Study coordinator: Erwei Song, M.D., Ph. D.

Conditions Breast Cancer; breast cancer,; tamoxifen,; ER/PR negative, ER-beta positive