Recruiting NCT07506876
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer - Infiltrating Ductal Carcinoma, HER-2 Positive Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery. The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery
Interventions
- Drug Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Primary outcome measures
- pCR Rates [Time frame: 21 months]
Secondary outcome measures (1)
- RCB scores [Time frame: 21 months]
Eligibility criteria
Inclusion criteria
- Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)
- Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy/HER2 directed therapy
- Choice of endocrine therapy will be determined by the treating and/or enrolling physician
- Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP
- Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy
Exclusion criteria
- Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.
- Patients with non-breast cancer within prior 2 years
- Patients with breast cancer within prior 5 years
- Patients with recurrent breast cancer
- Patients with stage IV breast cancer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Legacy Mount Hood Medical Center — Gresham
- Legacy Good Samaritan Medical Center — Portland
- Legacy Meridian Park Medical Center — Tualatin
- Legacy Salmon Creek Medical Center — Vancouver
Identifiers
NCT: NCT07506876 · 50876