Phase II Study of Hormone Therapy, Pertuzumab, and Trastuzumab for Stage I Hormone Receptor-Positive, HER2-Positive Breast Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04569747
This study is testing a combination of hormone therapy and two HER2-targeted drugs, pertuzumab and trastuzumab, given after surgery to treat hormone receptor-positive, HER2-positive breast cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This research is exploring a treatment plan that combines hormone therapy with two drugs, trastuzumab and pertuzumab, which target HER2-positive breast cancer. These drugs are given as an injection under the skin, known as PHESGO. The study aims to see if this combination is effective when used after surgery for patients with hormone receptor-positive breast cancer.
Description
In this study, participants will undergo screening to ensure they meet the eligibility criteria. The treatment involves receiving HER2-targeted therapy for one year and hormone therapy for about five years. Approximately 375 people are expected to participate in this Phase II clinical trial, which tests the safety and effectiveness of this drug combination.
Trastuzumab and pertuzumab are monoclonal antibodies, which are proteins made by cloned immune cells to fight disease. These drugs, along with the combination PHESGO, are approved by the FDA for treating HER2-positive breast cancer. Hormonal therapies are also approved for treating hormone receptor-positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with HER2-positive Stage I breast cancer, confirmed by tests.
- Cancer must be node-negative or have small clusters of cancer cells in the lymph nodes.
- Must have had surgery to remove the breast cancer.
- Hormone receptor-positive cancer, meaning the cancer grows in response to hormones.
- HER2-positive status confirmed by specific guidelines.
- Can have cancer in both breasts if each meets the criteria.
- Must have normal organ and blood function.
- Must be 18 years or older and in good overall health.
- Women must not be pregnant and must agree to use effective non-hormonal birth control during the study.
- Must be willing to provide tissue samples for research.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have had chemotherapy for this breast cancer before joining the study.
- Pregnant or nursing women cannot participate.
- Must not be using hormonal birth control methods.
- Cannot be participating in other breast cancer treatment studies without approval.
- Cannot have advanced tumors or a history of invasive breast cancer.
- Cannot have other serious health conditions that could interfere with the study.
- Must not have had other cancers unless they have been disease-free for at least 5 years, except for certain skin or cervical cancers.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.