Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLegacy Health System
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
DrugConcurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
pCR Rates
To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes
Time frame
21 monthsSecondary outcomes
1
RCB scores
To compare the distribution of RCB scores and nodal clearance rates between the two treatment groups and across the two molecular subtypes.
Time frame
21 monthsSponsors and contacts
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Source ClinicalTrials.gov