Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new evidence for the best treatment of HR low expression /HER2 negative advanced breast cancer, and to explore the efficacy and safety of combined/maintenance chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age ≥18 years old; Invasive breast cancer with metastatic disease confirmed by histological or cytological examination; Patients without pathologically or cytologically confirmed metastatic disease should have clear evidence of metastasis by physical examination or radiological studies;

• The most recent pathological report of biopsy confirmed HR low expression and HER2 negative.

∙ HR low expression was defined as 1-50% ER expression by immunohistochemistry (IHC); Or ER\<1% and PR≥1%; Patients with ER expression of 1-10% or ER-/ PR-positive patients were eligible for inclusion after careful evaluation by the investigator, and those with a small tumor burden and candidates for endocrine therapy were eligible.

‣ HER2-negative definition: IHC 0 or 1+; If the IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH).

• at least one measurable lesion;

• No previous salvage chemotherapy for metastatic disease was required, and first-line endocrine therapy was allowed;

• no previous CDK4/6 inhibitor; For adjuvant CDK4/6i treatment, recurrence and metastasis were required more than 1 year after drug withdrawal.

• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, life expectancy is more than 12 weeks;

• Adequate function of major organs.

• All adverse events recovered to grade 1 or less before enrollment (NCI CTCAE version 5.0);

• patients without major organ dysfunction and heart disease;

⁃ Women and men of childbearing potential must agree to use appropriate contraception before and during study participation.

Locations
Other Locations
China
Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Min Yan, M.D.
ym200678@126.com
+8615713857388
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 240
Treatments
Experimental: A
nab-paclitaxel 130mg/m2,day 1 and day 8 Capecitabine 2000mg/m2,from day1 to DAY 14 Vinorelbine 25mg/m2,day 1 and day 8
Active_comparator: B
palbociclib/Dalpiciclib Letrozole/Anastrozole/fulvestrant
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov

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