Ipatasertib + Endocrine Therapy for Breast Cancer

Palo Alto (17 mi)

Overseen byAditya Bardia, 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 am a premenopausal woman on hormone therapy with low estrogen levels.

My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).

I have had both of my ovaries surgically removed.

I am a postmenopausal woman with advanced or metastatic breast cancer.

My cancer has worsened after treatment, including hormone therapy.

My liver functions are within the required range.

I am able to care for myself and perform daily activities.

My blood tests show normal white blood cells, hemoglobin, and platelets.

I am a woman over 18 with HR+/HER2- breast cancer, confirmed by biopsy.

My LH and FSH levels indicate I am postmenopausal.

Exclusion Criteria

I do not have uncontrolled heart disease or abnormal heart rhythms.

I stopped taking CDK 4/6 inhibitor due to severe side effects.

I am not pregnant.

I use a highly effective form of birth control.

I have previously used an AKT inhibitor.

I do not have any serious illnesses or mental health issues that would stop me from following the study rules.

Treatment Details

The 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.

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