Trial Outcomes & Findings for Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca (NCT NCT01074814)

Results Overview

The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

28 participants

Primary outcome timeframe

6-20 weeks

Results posted on

2023-09-28

Participant Flow

The open-label multicenter pilot study accrued patients between March 2010 and June 2012. Three Oncology Practices contributed patients to the study.

Participant milestones

Participant milestones
Measure	Metastatic Breast Cancer Patients Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=25 Participants Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results
Age, Customized age	58 years n=5 Participants
Sex/Gender, Customized Female	25 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized White	23 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-20 weeks

Population: A total of 28 patients were enrolled and underwent tumor biopsy for the purposes of this study. 25/28 patients were treated on study with the MMP-selected treatment and were evaluable for the primary end point of GMI.

The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful.

Outcome measures

Outcome measures
Measure	Intervention n=25 Participants Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results
Growth Modulation Index (GMI) Greater Than or Equal to 1.3	25 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=25 participants at risk Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) Basis for decision making: treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results
Skin and subcutaneous tissue disorders hand-foot syndrome	12.0% 3/25 • Number of events 3 • adverse events grade 3 and 4 were collected for 2 years. The study is a molecular profiling study only. No research intervention.
Gastrointestinal disorders vomiting	8.0% 2/25 • Number of events 2 • adverse events grade 3 and 4 were collected for 2 years. The study is a molecular profiling study only. No research intervention.

Additional Information

Linda Vocila, Executive Director Clinical Strategy

Translational Drug Development

Phone: 6023588311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60