A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy
Recruiting
Phase 2
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 118 (estimated)
- Sponsor
- Zhejiang Cancer Hospital · Other
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About This Trial
* This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors;
* The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continue…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Sign an informed consent form;
2. Female, aged 18 or above;
3. The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;
4. The patient's expected survival time is ≥3 months;
5. Breast cancer patients diagnosed as HR-positive and HER-2 negative by tumor h…
Contacts