Treatment (SMMART-ACT) for Breast

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast+29 More
Biopsy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if cancer samples can be used to find drugs to control the disease. They will also study the safety and if the drugs have any side effects. Researchers will also study tumor cells to see why some people respond to certain therapies and why some drugs stop working.

Eligible Conditions
  • Breast
  • Anatomic Stage III Breast Cancer AJCC v8
  • Carcinoma
  • Malignant neoplasm of ovary
  • Malignant Neoplasms
  • Unresectable Ovarian Carcinoma
  • Locally Advanced Malignant Solid Neoplasm
  • Stage IIIC Ovarian Cancer AJCC v8
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Ovarian Carcinoma
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Refractory Ovarian Carcinoma
  • Stage IV Ovarian Cancer AJCC v8
  • Advance Directives
  • Stage III Ovarian Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Day 1 of SMMART-ACT intervention #1 up to date of disease progression, or death from any cause, assessed up to 60-months after the last dose of SMMART-ACT therapy #1

Month 60
Overall survival
Day 1
Progression free survival
Month 6
Proportion of participants that achieve clinical benefit (CR, PR or SD) per RECIST 1.1
Day 30
Incidence of treatment-emergent Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (SMMART-ACT)
1 of 1
Experimental Treatment

131 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (SMMART-ACT) · No Placebo Group · Phase 2

Treatment (SMMART-ACT)Experimental Group · 26 Interventions: Biopsy, Anastrozole, Cobimetinib, Capecitabine, Alectinib, Paclitaxel, Ado-Trastuzumab Emtansine, Letrozole, Quality-of-Life Assessment, Nab-paclitaxel, Niraparib, Vemurafenib, Biospecimen Collection, Carboplatin, Alpelisib, Vinorelbine, Atezolizumab, Bevacizumab, Entrectinib, Palbociclib, Hyaluronidase-zzxf/Pertuzumab/Trastuzumab, Fulvestrant, Vismodegib, Eribulin, Olaparib, Irinotecan · Intervention Types: Procedure, Drug, Drug, Drug, Drug, Drug, Biological, Drug, Other, Drug, Drug, Drug, Procedure, Drug, Drug, Drug, Biological, Biological, Drug, Drug, Biological, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Anastrozole
2019
Completed Phase 4
~10260
Cobimetinib
2015
Completed Phase 3
~2390
Capecitabine
2002
Completed Phase 3
~3010
Alectinib
2015
Completed Phase 3
~940
Paclitaxel
2011
Completed Phase 4
~6620
Ado-Trastuzumab Emtansine
2017
Completed Phase 1
~40
Letrozole
2005
Completed Phase 4
~4490
Nab-paclitaxel
2014
Completed Phase 3
~1680
Niraparib
2017
Completed Phase 2
~780
Vemurafenib
2015
Completed Phase 3
~2480
Biospecimen Collection
2004
Completed Phase 1
~670
Carboplatin
2014
Completed Phase 3
~7280
Alpelisib
2015
Completed Phase 1
~30
Vinorelbine
2013
Completed Phase 4
~1900
Atezolizumab
2015
Completed Phase 4
~7500
Bevacizumab
2014
Completed Phase 4
~5320
Entrectinib
2014
Completed Phase 1
~100
Palbociclib
2017
Completed Phase 3
~4630
Fulvestrant
2011
Completed Phase 3
~3810
Vismodegib
2016
Completed Phase 4
~980
Eribulin
2012
Completed Phase 3
~3270
Olaparib
2017
Completed Phase 4
~2090
Irinotecan
2010
Completed Phase 4
~4150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 of smmart-act intervention #1 up to date of disease progression, or death from any cause, assessed up to 60-months after the last dose of smmart-act therapy #1

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,487 Previous Clinical Trials
563,848 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
885 Previous Clinical Trials
6,828,410 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
206 Previous Clinical Trials
2,089,131 Total Patients Enrolled
Zahi Mitri, M.D.Principal InvestigatorOHSU Knight Cancer Institute
Lara Davis, M.D.Principal InvestigatorOHSU Knight Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must provide written informed consent before any study-specific procedures or interventions are performed.
You have a solid tumor malignancy that is metastatic, or locally-advanced and surgically unresectable, and have documented progression after receiving at least 1 line of approved prior therapy for your advanced or metastatic disease.
You have a tumor lesion located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion.
You have a disease that involves the bones and/or joints, but the disease does not involve the soft tissues.
A participant who is able to undergo a biopsy or has tissue available collected within the past 90 days for assessment using SMMART-CAP, and has not received more than 1 intervening treatment for their cancer during this 90 day interval time.
Participants with solid tumors must have measurable disease as defined by RECIST version (v)1.1.1.
Participants with a solid tumor must have a lesion meeting the above criteria also and must be amenable to biopsy procedures performed per institutional standards.
Patients with prostate cancer who have no measurable disease may be considered eligible for study participation.
You are undergoing a biopsy during the pre-screening period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.