Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT05933395
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
    Fulvestrant will be administered intramuscularly into the buttocks in combination with one of the other interventions as outlined above.
  • Neratinib — DRUG
    Neratinib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.
  • Alpelisib — DRUG
    Alpelisib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.
  • Everolimus — DRUG
    Everolimus will be administered orally in tablet form once daily in combination with fulvestrant administration as outlined above.
  • Abemaciclib — DRUG
    Abemaciclib will be administered orally in tablet form twice daily in combination with fulvestrant administration as outlined above.

Study Details

The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.

Key Dates

Start date
Sep 23, 2024
Status verified
Jan 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2031

Study Design

Enrollment
135 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm A- neratinib and fulvestrant
    Participants with a qualifying ERBB2 (HER2) mutation will be assigned to Treatment Arm A and given the combination of neratinib and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Neratinib will initially be administered orally in 3 tablets (total dose of 120 mg) taken 1 time per day with food on Cycle 1 Days 1-7, in combination with fulvestrant starting on Cycle 1 Day 1 as described above. The dose of neratinib will be increased to 4 tablets (total dose of 160 mg) taken 1 time per day with food on Cycle 1 Days 8-14, and then increased further to 6 tablets (240 mg) taken once daily with food thereafter.
  • Experimental: Arm B- alpelisib and fulvestrant
    If a participant does not have a qualifying ERBB2 (HER2) mutation, but they have a qualifying PIK3CA mutation, the subject will be assigned to Treatment Arm B and given the combination of alpelisib and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Alpelisib will be administered orally in 2 tablets (total dose of 300 mg) taken 1 time per day with food, in combination with fulvestrant as described above.
  • Experimental: Arm C- everolimus and fulvestrant
    If a subject does not have a qualifying ERBB2 or PIK3CA mutation, but they have a qualifying mutation/alteration in AKT1, MTOR, or PTEN, the subject will be assigned to Treatment Arm C and given the combination of everolimus and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Everolimus will be administered orally in 1 tablet (10 mg per tablet) taken 1 time per day, in combination with fulvestrant as described above.
  • Experimental: Arm D- abemaciclib and fulvestrant
    If a participant does not have a qualifying mutation/alteration for Arms A/B/C, and the participant does not have mutation or loss of RB1, the subject will be assigned to Treatment Arm D and given the combination of abemaciclib and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Abemaciclib will be administered orally in 1 tablet (150 mg) taken 2 times per day, in combination with fulvestrant as described above.

Primary Outcome Measure

Rate of clinical benefit within each arm in patients previously treated with a CDK4/6 inhibitor. [ Time Frame: 6 - 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756
Research Nurse
[email protected]
603-650-5021
Rachel Wierzbicki
6036505021

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By research site
Dartmouth Hitchcock Medical Center· Lebanon, NH

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