Endocrine Therapy vs Chemotherapy for Breast Cancer
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
35 – 55
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
234 (estimated)
Sponsor
Peking University · Other
Who this trial is looking for
This trial is looking for premenopausal women with certain types of breast cancer. Participation involves receiving either endocrine therapy or chemotherapy and regular check-ups to see how the treatment is working.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 35 to 55 years old and premenopausal.
I have been diagnosed with primary invasive breast cancer.
My breast cancer is HR+ (hormone receptor positive) and HER2 negative.
I have T2N0M0 stage breast cancer that makes surgery difficult.
I have not received any other treatment for my breast cancer.
I do not have any other tumors or uncontrolled infections.
I am willing to participate and will sign the informed consent.
You may not be able to join if
I have metastatic breast cancer.
I have a history of another type of tumor.
I have serious heart or brain vessel problems.
I have liver or kidney dysfunction.
I have blood system diseases.
I have a psychological condition or mental disorder.
I am involved in another clinical trial.
I do not wish to participate in the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
* Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasib…
Inclusion Criteria:
* 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
* Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
* Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
* No other previous treatment for primary breast cancer
* Without other tumor or unstable complication or uncontrolled infection
* No contradiction for the third generation AIs, LHRHa, chemotherapy
* Attend the study voluntarily, sign the informed consent.
Exclusion Criteria:
* Metastasis disease by pathological or radiological diagnosis
* the history of other tumor
* contradiction for the third generation AIs, LHRHa, chemotherapy
* Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
* Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
* other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
* have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study
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