Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06810492 | NOT YET RECRUITING | Breast Cancer Stage III

The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
Sponsor:

hong z 间, PhD

Information provided by (Responsible Party):

hong z 间, PhD

Brief Summary:

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer. This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

Condition or disease

Breast Cancer Stage III

Breast Cancer Stage II

Intervention/treatment

Ribociclib; abemaciclib; palbociclib; Dalpiciclib

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2027-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age ≥ 18 years old.
  • 2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR\>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
  • 3. Patients must have histologically confirmed ER and/or PR \>10%, HER2-, early invasive breast cancer.
  • 4. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
  • 5. ECOG PS score 0-2.
  • 6. Patients must be able and willing to swallow and retain oral medications.
  • 7. Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test.
  • 8. Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy.
  • 9. Absolute neutrophil count ≥ 1500/µL, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dL
Exclusion Criteria
  • 1. Prior treatment with any CDK inhibitor.
  • 2. Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
  • 3. History of anaphylaxis caused by chemical or biologic components similar to dalsily.
  • 4. Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
  • 5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
  • 6. Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.
  • 7. Patients with any history of malignancy are not eligible.
  • 8. Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment

Location Details

NCT06810492

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found