Combining Dalpiciclib with aromatase inhibitors for breast cancer treatment
Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Single-arm, Open-label Trial
PHASE2 · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT05640778
This study is testing whether combining Dalpiciclib with aromatase inhibitors can help women with Luminal B/HER2-negative breast cancer feel better before surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05640778 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Dalpiciclib when used alongside aromatase inhibitors as a neoadjuvant therapy for patients with Luminal B/HER2-negative breast cancer. The study focuses on female patients with stage I-III breast cancer who have not received prior anti-cancer treatments. Participants will be monitored for their response to the treatment and any potential side effects throughout the trial. The goal is to determine if this combination therapy can improve outcomes for this specific breast cancer subtype.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with stage I-III HR-positive, HER2-negative invasive breast cancer.
Not a fit: Patients with other aggressive malignancies, inflammatory breast cancer, or those with serious concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective neoadjuvant therapy option for patients with Luminal B/HER2-negative breast cancer.
How similar studies have performed: Other studies have shown promise with similar combination therapies in breast cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is ≥ 18 years-old at the time of consent to participate this trial * Famale stage I-III breast cancer patients * HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR\<20% * No prior anti-cancer treatment * ECOG 0-1 Exclusion Criteria: * Known to have other aggressive malignant tumor in the past 5 years. * Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology. * There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * Female patients during pregnancy or lactation. * The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Where this trial is running
Hangzhou
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, China (RECRUITING)
Study contacts
- Study coordinator: Yunxiang Zhou
- Email: yxzhou@zju.edu.cn
- Phone: +8615868131018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Luminal B/HER2-negative Breast Cancer