Endocrine Therapy for Breast Cancer

Palo Alto (17 mi)

Overseen byPriscilla McAuliffe, MD

Age: Any Age

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Priscilla McAuliffe

Stay on your current meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype. PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy. Primary Objective: To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).

Eligibility Criteria

This trial is for postmenopausal women with a specific type of breast cancer called invasive lobular carcinoma, which is hormone receptor-positive and HER2-negative. They should be in clinical stages I-III, have a tumor at least 1 cm large, and an ECOG performance status of 0 to 2 indicating they are fully active or can do light work.

Inclusion Criteria

I can take care of myself and perform daily activities.

I am female.

I have gone through menopause completely.

My breast cancer is invasive, not spread widely, hormone-sensitive, HER2-negative, and at least 1cm big.

Exclusion Criteria

I have used hormone, chemo, radiation, or new treatments for my current breast cancer.

I do not have active hepatitis or severe liver disease.

My cancer is HER-2 positive.

I have a history of bleeding easily or very low platelet counts.

I am allergic to tamoxifen, anastrozole, fulvestrant, or their ingredients.

I have a history of blood clots or uterine cancer that makes tamoxifen unsafe for me.

I do not have any uncontrolled illnesses that could affect my participation.

Treatment Details

The study tests the effectiveness of three drugs—fulvestrant, anastrozole, and tamoxifen—in reducing Ki67 levels in breast cancer tissue. This reduction may indicate how well these treatments could work for this subtype of breast cancer. Women will receive one of these drugs before their surgery or further treatment.

3Treatment groups

Active Control

Group I: fulvestrantActive Control1 Intervention

500 mg, administered as two 250 mg IM injections, given on days 1 and 14

Group II: tamoxifenActive Control1 Intervention

Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days

Group III: AnastrozoleActive Control1 Intervention

1mg given orally daily for 21 days

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: