Clinical trial NCT04655573: A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer
Official title: A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Advanced Breast Cancer
Keywords: Patient derived micro-organospheres (PDMO)
Chemotherapy
Advanced Breast Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with advanced breast cancer

Brief summary: The purpose of this study is to assess the feasibility of generating patient derived micro-organospheres (PDMO) from patients with advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.

Detailed description: The purpose of this study is to determine the feasibility of generating sufficient patient derived micro-organospheres (PDMO) from a biopsy of a patient's advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care. While subjects are on study, they will first receive a standard of care clinical biopsy from which extra tissue is taken for research purposes. Following the biopsy, a PDMO will be generated and they will receive a chemotherapy regimen as determined by their treating physician. This study aims to enroll 15 patients. Of this 15 patient cohort we aim to enroll 5 patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) disease, 5 patients with ER+/HER2+ or ER-/HER2+ disease, and 5 patients with ER-/HER2- (TNBC) disease. There are risks to having biopsies and blood draws that may include moderate bleeding and pain at the biopsy site.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent.
2. Female ages 18 or older.
3. Have measurable disease ≥ 2 cm defined by RECIST version 1.1.
4. Amenable to standard of care biopsy with co-consent to the Duke BioRepository \& Precision Pathology Center (BRPC) protocol (Pro00035974) to collect extra biopsy tissue for research or willing to provide extra tissue other than standard of care without co-consent to BRPC.
5. Evidence of advanced cancer of the breast that is surgically unresectable with pathology confirming ER, PR, and HER2 status. NOTE: patients may enroll prior to receiving clinical biopsy results based on historical pathology results.
6. Patient is eligible for chemotherapy as monotherapy or in combination with single-agent anti HER2 Therapy.

   * ER+/PR+/HER2-, must have progressed or be intolerant to CDK 4/6 inhibitor and/or endocrine therapy unless CDK 4/6 inhibitor is not able to be provided per the clinician's discretion endocrine therapy and CDK 4/6 inhibitor
   * ER+/PR+/HER2+ or ER-/PR-HER2+, must have progressed or be intolerant to ≥ 2 lines of anti-HER2 therapy and be considered for mono-chemotherapy with trastuzumab and/or anti-HER2 tyrosine kinase inhibitor
   * ER-/PR-HER2-, PD-L1- and/or TMB \<10 may may be considered for first line of treatment
7. Treating physician is planning to treat breast cancer in the advanced setting with a chemotherapy backbone. This study excludes patients who will receive an antibody-drug conjugate as their proposed treatment.
8. Impending visceral crisis is allowed only if the patient can have a biopsy prior to starting systemic mono-chemotherapy
9. ECOG performance status of 0, 1, or 2.
10. Any metastatic site that is ≥ 2cm and amenable to core needle biopsy. Patients with brain metastases are allowed and MOS may be generated from a resected breast cancer brain metastasis

Exclusion Criteria:

1. Actively requiring systemic antibiotics.
2. Clinically significant cardiac disease, including unstable angina or acute myocardial infarction within 6 months of enrollment.
3. Leptomeningeal disease
4. Pregnant women.
5. Enrolling on an investigational agent.

Primary outcomes:
measure: The proportion of patients with successful generation of PDMO from the patient's biopsy
timeFrame: 10 days of biopsy
Secondary outcomes:
measure: Association between specific chemotherapy sensitivity in PDMO to clinical outcome of patient
timeFrame: End of study (up to 2 years)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Susan Dent
role: PRINCIPAL_INVESTIGATOR
References: