Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Canc… (NCT06009627) | Clinical Trial Compass
CompletedPhase 2/3
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
China119 participantsStarted 2023-04-11
Plain-language summary
A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment
Who can participate
Age range
18 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients were operable estrogen receptor (ER) positive (\>1%), regardless of PR expression level, HER2 receptor negative invasive breast cancer. Follow the 2018 ASCO-CAP HER2 negative interpretation guideline standard. Confirmed by the pathological laboratory that the immunohistochemical (IHC) score is 0 or 1-2+and the in situ hybridization (ISH) test is negative (ISH amplification rate\<2.0);
* Stage II-III initial treatment patients whose tumor staging meets the AJCC 8th edition standards;
* At least one measurable breast and/or axillary disease;
* ECOG 0-1, with an estimated lifespan of at least 12 months;
* The functional level of the main organs must meet the following requirements:
Blood routine: ANC ≥ 1.5 × ten9/L; PLT ≥ 90 × ten9/L; Hb ≥ 90 g/L;Blood biochemistry: TBIL ≤ 2.5 × ULN; ALT and AST ≤ 2.5 × ULN; BUN and Cr≤ 1.5 × ULN;
* Lead ECG: QT interval (QTcF) corrected by Fridericia method\<470 ms for women;
* Able to accept all puncture biopsies required by the protocol;
* Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up;
* Women with fertility potential must have a negative Pregnancy test (urine or serum) within 7 days after administration,
And agree to use acceptable birth control methods during the study period to avoid pregnancy.
Exclusion Criteria:
* Received any form of anti-tumor treatment within 28 days prior to the start of the study;
* Simultaneously receivi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) for treatment
Timeframe: At the end of the second cycle (each cycle is 21 or 28 days)
Trial details
NCT IDNCT06009627
SponsorTianjin Medical University Cancer Institute and Hospital