DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients

Mayo Clinic

Status: Enrolling

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Hormone-receptor-positive Breast Cancer; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; HER2 Negative Breast Carcinoma; Metastatic Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Breast Carcinoma

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other

Identifiers

NCT06388122

23-009689

MC240301 (Other Identifier)

Details and patient eligibility

About

This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre- or post-menopausal HR+ metastatic breast cancer patients who are:

  • Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).
  • Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
  • Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
  • Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.
  • Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC

NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.

Exclusion criteria

• Treatment including investigational agent or therapies

• Early breast cancer diagnosis

• Male breast cancer

• Currently receiving treatment for other active malignancy at time of registration

  • EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)

• Inability to give written informed consent

Trial design

100 participants in 5 patient groups

Group 1 (initiating 1st line CDK4/6 & endocrine therapy)

Description:

Patients scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Treatment:

Procedure: Biospecimen Collection

Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy)

Description:

Patients scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Treatment:

Procedure: Biospecimen Collection

Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy)

Description:

Patients currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn on day 15 of the next cycle after enrollment and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Treatment:

Procedure: Biospecimen Collection

Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)

Description:

Patients scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA-approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Blood will be drawn at baseline or the first day of the treatment cycle and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.

Treatment:

Procedure: Biospecimen Collection

Group 5

Description:

Patients scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage II or stage III adjuvant HR+ BC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.

Treatment:

Procedure: Biospecimen Collection