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AKT Inhibitor

Ipatasertib for Breast Cancer (IPATunity130 Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment up to death from any cause, up to 1 year
Awards & highlights

IPATunity130 Trial Summary

This trial will compare the effectiveness of a new drug combination versus a placebo for people with aggressive breast cancer that has spread.

Eligible Conditions
  • Breast Cancer

IPATunity130 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

IPATunity130 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment up to death from any cause, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment up to death from any cause, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Progression-Free Survival (PFS)
Cohort B: PFS
Cohort C: PFS
Secondary outcome measures
Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30
Cohort A and B: Clinical Benefit Rate (CBR)
Cohort A and B: Duration of Response (DOR)
+17 more

IPATunity130 Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo + PaclitaxelExperimental Treatment2 Interventions
Group II: Ipatasertib + PaclitaxelExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2019
Completed Phase 3
~2340
Paclitaxel
2011
Completed Phase 4
~5380
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,553 Total Patients Enrolled
159 Trials studying Breast Cancer
90,888 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
887,981 Total Patients Enrolled
137 Trials studying Breast Cancer
71,517 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Paclitaxel most often prescribed?

"Neoplasm metastasis is most commonly treated with Paclitaxel. Paclitaxel is also effective at treating other conditions such as kaposi sarcoma, fallopian tubes cancer, and ovarian cancer."

Answered by AI

Could you please explain the dangers associated with Paclitaxel?

"Paclitaxel has been given a score of 3 for safety by our team at Power. This is because Phase 3 trials, of which this is one, provide some evidence of efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Could you please tell me what other scientific research has been conducted with Paclitaxel?

"At this moment, 899 different clinical trials for Paclitaxel are ongoing with 236 of them being in Phase 3. Most of the research for Paclitaxel is being conducted in Adelaide, South Australia; however, there are 47776 total locations running clinical trials for Paclitaxel."

Answered by AI
Recent research and studies
~81 spots leftby Mar 2025