A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Summary

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy \[SMMART\])-adaptive clinical treatment \[ACT\]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

Conditions

• Advanced Breast Carcinoma
• Advanced Malignant Solid Neoplasm
• Advanced Ovarian Carcinoma
• Advanced Pancreatic Carcinoma
• Advanced Prostate Carcinoma
• Advanced Sarcoma
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Interventions

DRUG

Abemaciclib

Given PO

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Echocardiography

Undergo echocardiography

DRUG

Exemestane

Given PO

DRUG

Gemcitabine

Given IV

DRUG

Letrozole

Given PO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Osimertinib

Given PO

DRUG

Pemetrexed

Given IV

OTHER

Survey Administration

Ancillary studies

DRUG

Tamoxifen

Given PO

PROCEDURE

Biospecimen Collection

Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• Eli Lilly and Company

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Charles D Lopez, MD, PhD · OHSU Knight Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-24

Primary Completion

2026-03-11

Completion

2026-03-11

FDA Drug

Yes

Countries

• United States

Study Locations