NCT05728268 Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
| NCT ID | NCT05728268 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shantou Central Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2021-08-01 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
Eligibility Criteria
Inclusion Criteria: * Females with age of 18 to 70 years old. * Newly diagnosed breast cancer patients. * Planned neoadjuvant chemotherapy. * Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive. * HER2/neu-negative. * Ki67≥30%. * Clinical stage IIB-IIIC. * Informed consent form understood and signed. * Patient agrees to all follow-up visits. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Women of childbearing potential must have a negative serum pregnancy test. Exclusion Criteria: * Metastatic disease * Pregnancy. * Nursing mothers. * Active or uncontrolled infection. * Presence of another malignancies. * Granulocyte count \< 1.5\*10\^9/L. * Platelet count \< 100\*10\^9/L. * Hemoglobin \< 90g/L. * Serum Creatinine more than 1.5 upper limit. * AST and ALT more than 2.5 upper limit. * LVEF\< 50%.
Frequently Asked Questions
Who can join the NCT05728268 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05728268 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05728268 currently recruiting?
Yes, NCT05728268 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shantou Central Hospital to inquire about joining.
Where is the NCT05728268 trial being conducted?
This trial is being conducted at Shantou, China.
Who is sponsoring the NCT05728268 clinical trial?
NCT05728268 is sponsored by Shantou Central Hospital. The trial plans to enroll 64 participants.
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