Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

Plain-language summary

This study evaluated targeted treatments (Alpelisib, Tamoxifen, Zotatifin and Fulvestrant) chosen according to tumor subtype in patients with ER-positive, HER2-negative breast cancer. It enrolled women and men aged 18 and older whose breast tumor was still in place. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Jennifer Lee Caswell-Jin

Intervention

Alpelisib, Tamoxifen, Zotatifin, Fulvestrant

Start date

3/20/2023

Estimated completion

6/3/2024

Countries

United States

Related genes

Locations

• Stanford, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Pre-Screening Phase
* Biopsy-proven ER-positive, HER2-negative breast cancer. ER-positivity and PR-positivity are defined as ≥1% cells staining positive by immunohistochemistry. HER2-negativity is defined by IHC or FISH, per ASCO-CAP 2018 guidelines. Breast tumor must be intact and tumor size must be ≥ 1 cm as measured by ultrasound, mammogram, MRI, or clinical exam. If tumor is locally recurrent, it must be in the breast (not skin, node, or chest wall recurrence). Ki67 may or may not have been done locally but if done locally, must be ≥ 5%. Any nodal status is allowed, as M0 or M1 disease.
* Women or men, age ≥ 18 years old.
* Performance status 0 to 1 (by Eastern Cooperative Oncology Group \[ECOG\] scale).
* Ability to understand and the willingness to sign a written informed consent document.

Treatment Phase

* Breast tumor classifies as relevant integrative subtype per tumor sequencing performed and analyzed by central laboratory.
* Breast tumor Ki67 score ≥ 10% as assessed by central laboratory.
* Each investigational agent specific inclusion criteria can be found in the agent-specific appendix

Exclusion Criteria:

* Pregnant woman, as confirmed by positive serum hCG test prior to initiating study treatment. Nursing (lactating) woman also not allowed.
* Prior breast cancer-directed therapy (surgery, radiation, chemotherapy, or endocrine therapy) is not allowed, with the exception of people with in-breast recurrences. People with in-breast recurrences cannot have had breast cancer-directed therapy (radiation, chemotherapy, or endocrine therapy; surgery is acceptable) within the 6 months prior to signing the pre-screening consent. Pre-endocrine therapy for breast cancer risk reduction is allowed.
* Known hypersensitivity to study agent (IP) or standard endocrine therapy drug, or to any of the excipients of study agent (IP) or standard endocrine therapy drug.
* Each study agent specific exclusion criteria can be found in the agent-specific appendix