Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)
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
- Female only
- 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 certain drug combinations work for advanced ER-positive, HER2-negative breast cancer. This cancer uses estrogen to grow and does not have high levels of HER2. The study is for women past menopause who have already taken palbociclib, ribociclib, or abemaciclib.
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older who are past menopause. Breast cancer must have spread or come back near its original site and cannot be treated with the goal of a cure.
- Cancer must be ER-positive and HER2-negative based on lab tests. The study doctor will decide if unclear HER2 results qualify.
- Must have taken palbociclib, ribociclib, or abemaciclib for advanced cancer. Up to 3 treatment courses after that drug, any number of hormone treatment courses, and up to 1 chemotherapy course are allowed.
- A biopsy (tissue or cell sample) must confirm ER-positive cancer where it spread or returned. Some people may qualify without a new biopsy if cancer is mainly in the bones or a safe, accurate biopsy is hard to get.
- Must have gene testing on a tumor or blood sample taken after cancer worsened on the prior drug. Testing must cover the genes needed for this study and meet lab standards. The study can arrange testing if needed.
- Stored tumor tissue, if available, must be shared for research in a large enough amount.
- Must have scans to check the cancer's spread: a PET/CT scan, or a CT scan with contrast dye of the chest, belly, and pelvis plus a bone scan.
- Must be able and willing to give written consent to join.
Who can't join
- Abemaciclib is part of your current or most recent treatment.
- Other cancer treatments during the study treatment periods, except bone-protecting drugs such as bisphosphonates or denosumab.
- An experimental cancer treatment within the last 3 weeks.
- Known untreated cancer in the brain or spinal cord, unless it has been stable for at least 3 months.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Post-menopausal women ≥18 years of age with metastatic ER+ breast cancer, or with locally recurrent ER+ disease not amenable to therapy for curative intent. 2. Patient must be post-menopausal per NCCN guidelines. 3. Patient must have been treated with a CDK4/6i (either palbobclib, ribociclib, or abemaciclib) alone or in combination with an endocrine agent in the advanced disease setting. * Up to 3 lines of therapy following CDK4/6i are permissible. * Any number of prior lines of endocrine-containing therapy is permissible. * Up to 1 prior line of chemotherapy is permissible. 4. Histologic documentation of ER+ breast cancer by core needle biopsy, fine needle aspiration, incisional biopsy, or surgical biopsy of ≥1 site(s) of metastatic or locally recurrent disease performed as standard of care. * Exceptions: patients with bone-dominant metastatic disease, or non-bone metastatic disease in whom a safe and accurate biopsy of recurrent/metastatic disease cannot be readily obtained, with a history of ER+ breast cancer are eligible, and biopsy is not required, providing their primary cancer is consistent with the ER criteria described below. 5. ER+ status defined as ER staining by immunohistochemistry in ≥1% of malignant cell nuclei. 6. Tumor must be HER2-non-amplified as defined by an immunohistochemistry score of 0-1+, or with a FISH ratio \<2 if IHC is 2+ or if IHC has not been done (as per ASCO/CAP definitions). In cases of borderline or equivocal HER2 status, eligibility will be determined by the PI. 7. Genetic profiling of a tumor or plasma specimen acquired after disease progression on a CDK4/6i must have been performed in a CAP-accredited, CLIA-certified laboratory using clinically validated methods. Profiling must minimally include analysis of study-relevant alterations in ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1. * If not done: Profiling of a tumor (preferable) or plasma specimen will be performed as part of the study in the DHMC Pathology Laboratory. A plasma specimen may be obtained for study-specific genetic profiling to direct treatment assignment. Tumor specimens must be obtained outside of this study (e.g., by biopsy). 8. If available, archived tumor tissue must be accessible for research purposes, sufficient to make ≥10 five-micron sections; more tumor tissue is preferred. 9. Radiographic staging performed as standard of care, including specifically either PET/CT, or contrast CT (CAP) and bone scan. 10. Patient must be capable and willing to provide informed written consent for study participation. Exclusion Criteria: 1. Treatment with abemaciclib in the most recent or current line of therapy. 2. During the study Treatment Phases, no concurrent anti-cancer therapies are allowed with the following exception: anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted. 3. Any investigational cancer therapy in the last 3 weeks. 4. Known untreated CNS disease, unless clinically stable for ≥ 3 months.
Study sites (1)
NH
- Dartmouth Hitchcock Medical Center · Lebanon, NH 03756Research Nurse · Study contact · 603-650-5021 · hem-onc.research.nurses@hitchcock.orgRachel Wierzbicki · Study contact · 6036505021More trials in Lebanon