Ipatasertib + Endocrine Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen bySeth Wander, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is exploring the safety/tolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR+ breast cancer.

Eligibility Criteria

This trial is for postmenopausal women with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. They must have had disease progression after prior therapy and should not be on certain antiretroviral therapies or have uncontrolled illnesses. Women of childbearing potential are excluded unless they use effective contraception.

Inclusion Criteria

I have previously been treated with mTOR or PI3K inhibitors.

I am a premenopausal woman on hormone therapy with low estrogen levels.

I have at least one cancer lesion that can be measured.

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Exclusion Criteria

My brain metastases are stable, and I haven't taken steroids for over a month.

I practice total abstinence as my usual form of lifestyle.

I am using or will use effective birth control during and 8 weeks after the study.

See 12 more

Treatment Details

Interventions

Aromatase Inhibitor (Hormone Therapy)
Fulvestrant (Hormone Therapy)
Ipatasertib (AKT Inhibitor)
Palbociclib (CDK 4/6 Inhibitor)

Trial OverviewThe TAKTIC study tests if Ipatasertib combined with an Aromatase inhibitor or Fulvestrant improves outcomes in breast cancer treatment. It's designed to see how well patients respond to this combination compared to their previous treatments.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Fulvestrant + Ipatasertib +PalbociclibExperimental Treatment3 Interventions

* Ipatasertib will be administered orally on a 3 week on and 1 week off schedule * Fulvestrant would be administered as intra-muscular injection twice a month for the first cycle, and then monthly for all other cycles. * Palbociclib will be administered orally on a 3 week on and 1 week off schedule

Group II: Fulvestrant + IpatasertibExperimental Treatment2 Interventions

* Ipatasertib will be administered orally on a daily basis * Fulvestrant would be administered as intra-muscular injection twice a month for the first cycle, and then monthly for all other cycles.

Group III: Aromatase Inhibitor + IpatasertibExperimental Treatment2 Interventions

* Ipatasertib will be administered orally on a daily basis * Aromatase inhibitors will be administered orally on a daily basis