Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ruth O'Regan
Study ID
NCT04886531
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Neratinib — DRUG
    120mg for 7 days; 160mg for 7 days ; 240mg for 7 days. 240 mg (up to a maximum of 24 weeks) orally daily\*.
  • Letrozole (L) or Anastrozole (A) — DRUG
    L: (2.5 mg) OR A: (1 mg) orally daily (up to a maximum of 24 weeks)\*
  • Trastuzumab — DRUG
    All Arms 8mg/kg loading dose followed by 6mg/kg every 3 weeks administered every 3 weeks by IV starting wk 4. Trastuzumab biosimilars may be used per institutional guidelines.

Study Details

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

Key Dates

Start date
Jul 21, 2022
Status verified
Apr 2026
Primary completion
Jun 22, 2026
Completion
Jul 21, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Weeks 1-3\* patients receive either (a) Neratinib, (b) Letrozole or Anastrozole or (c) Neratinib + Letrozole or Anastrozole Weeks 4-24 patients receive Neratinib + Letrozole or Anastrozole and Trastuzumab \*Starting drug intervention varies for the first 3 weeks depending on arms: a, b, and c by randomization.

Primary Outcome Measure

Pathologic Complete Response (pCR) [ Time Frame: 24 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612
Oana Danciu, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642
Lisa Carrozzi, OCN
[email protected]
585-533-1905
Kathleen Pratt
[email protected]
585-533-1908
Ruth O'Regan, MD (PRINCIPAL_INVESTIGATOR)
Penn State Cancer InstituteHersheyPennsylvania17033
Monali Vasekar, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
UW Cancer Connect
800-622-8922
Kari Wisinski, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Illinois Cancer Center· Chicago, ILUniversity of Rochester Medical Center· Rochester, NYPenn State Cancer Institute· Hershey, PAUniversity of Wisconsin· Madison, WI

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