RightFit
RecruitingPhase 2

Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding hormone-blocking treatment to chemotherapy and HER2-targeted treatment before surgery helps breast cancer respond better. It is for adults with newly diagnosed stage IIA–IIIC breast cancer that is hormone receptor positive (HR+) and HER2 positive (HER2+). These cancers have hormone receptors and a protein called HER2 that help them grow.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 with newly diagnosed HR+, HER2+ breast cancer.
  • Have had no treatment for this cancer, except hormone-blocking treatment started within 28 days before joining.
  • Start hormone-blocking treatment before the second cycle of chemotherapy and HER2-targeted treatment. Your doctor chooses the hormone-blocking treatment.
  • Have stage IIA–IIIC breast cancer and plan to get at least 4 cycles of TCHP, a mix of chemotherapy and HER2-targeted drugs.
  • Have a MammaPrint/BluePrint test on the first breast tissue sample showing one of these cancer types: Luminal A, Luminal B, or HER2-enriched.

Who can't join

  • Be younger than 18.
  • Be pregnant.
  • Be a prisoner.
  • Be an adult who cannot make informed decisions.
  • Have had cancer other than breast cancer in the past 2 years.
  • Have had breast cancer in the past 5 years.
  • Have breast cancer that has come back.
  • Have stage IV breast cancer, which has spread to distant parts of the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines) 1. 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 2. Choice of endocrine therapy will be determined by the treating and/or enrolling physician 2. Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP 3. Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy Exclusion Criteria: 1. Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults. 2. Patients with non-breast cancer within prior 2 years 3. Patients with breast cancer within prior 5 years 4. Patients with recurrent breast cancer 5. Patients with stage IV breast cancer

Study sites (4)

OR

WA