DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

Summary

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease.

Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

Conditions

• Ductal Carcinoma in Situ

Interventions

DRUG

Tamoxifen

For premenopausal women: 20 mg tamoxifen orally daily (standard dose) or 10 mg every other day (low dose). For postmenopausal women who are not tolerating an AI, investigators can change them to the low dose (10 mg every other day) or standard dose (20 mg) of tamoxifen.

DRUG

Exemestane

For postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, or reduced exemestane dosing: 25 mg 3 times per week orally

DRUG

Letrozole

For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.

DRUG

Anastrazole

For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.

DRUG

Testosterone + Anastrazole

Investigational drug. Both pre- and post- menopausal subjects. 100mg testosterone in combination with 4mg anastrazole administered subcutaneously every 3 months for up to 3 years.

DRUG

Elacestrant

Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.

DRUG

Z-endoxifen

Investigational drug. Both pre- and post- menopausal subjects. (z)-endoxifen 10mg delayed release capsule 1 hour before a meal or 2 hours after a meal once daily for up to 36 months.

Sponsors & Collaborators

• QuantumLeap Healthcare Collaborative

  lead OTHER

Principal Investigators

• Laura Esserman, MD, MBA · University of California, San Fancisco - Department of Surgery

• (Co-PI) Kelly Hewitt, MD, FACS · Huntsman Cancer Institute at the University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-17

Primary Completion

2028-11-30

Completion

2033-11-30

FDA Drug

Yes

Countries

• United States

Study Locations