Anastrozole + Palbociclib for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAntoinette Tan, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Antoinette Tan, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests the safety and feasibility of using two drugs, anastrozole and palbociclib, together. It targets postmenopausal women with a specific type of breast cancer that may not respond well to other treatments. The treatment works by lowering estrogen levels and stopping cancer cells from growing. Anastrozole is used to significantly reduce plasma estrogen levels in postmenopausal women with advanced breast cancer.

Eligibility Criteria

This trial is for postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. It's open to those who haven't had treatment for metastatic disease (Cohort A) or as maintenance after first-line chemo (Cohort B). Participants need measurable disease, good performance status, and normal organ function. Pre/peri-menopausal women must be on LHRH agonist therapy.

Inclusion Criteria

I am 18 years old or older.

I can take care of myself and am up and about more than half of my waking hours.

My cancer can be measured by scans or is only in my bones.

+9 more

Exclusion Criteria

I do not have active brain metastases or related conditions.

You are allergic to anastrozole.

I am not taking any strong medications that affect liver enzymes.

+8 more

Participant Groups

The study tests combining anastrozole with palbociclib in two groups: one receiving it as a first-line therapy and the other as maintenance post-chemo. It's an open-label pilot study where patients are assigned to either Cohort A or B based on their treatment history.

2Treatment groups

Experimental Treatment

Group I: Cohort B: Maintenance therapyExperimental Treatment2 Interventions

Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle

Group II: Cohort A: First-line therapyExperimental Treatment2 Interventions

Anastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Arimidex for:

Breast cancer
Early breast cancer in postmenopausal women

🇺🇸 Approved in United States as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

🇯🇵 Approved in Japan as Arimidex for: