Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06075953

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

Led by QuantumLeap Healthcare Collaborative · Updated on 2026-05-11

400

Participants Needed

27

Research Sites

506 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, at least 18 years old
  • Previous diagnosis of hormone receptor positive DCIS (at least 50% ER or PR) with or without microinvasion
  • Patients with hormone positive DCIS who had surgery with positive margins not re-excised
  • At least 4-6 weeks washout if previously received endocrine therapy before screening MRI
  • Bilateral mammogram within 6 months or diagnostic unilateral mammogram within 12 months prior to treatment
  • MRI on approved scanner within 2 months before treatment
  • Normal or clinically acceptable CBC, CMP, and lipid panel within 1 year before treatment
  • Negative urine or serum pregnancy test within 1 month before treatment
  • Controlled HIV positive patients allowed if medications do not conflict with study drugs
  • Willing and able to provide tumor samples for research
Not Eligible

You will not qualify if you...

  • Pregnant or actively breastfeeding women
  • Allergic reactions to similar compounds as study drugs
  • Presence of invasive carcinoma or MRI-detected mass confirmed as invasive cancer
  • Participation in other clinical trials with investigational drugs
  • Ongoing treatment for DCIS outside of this study protocol
  • Uncontrolled illnesses or psychiatric conditions limiting study compliance
  • Gastrointestinal disorders affecting drug absorption, including active inflammatory bowel disease, chronic diarrhea, active hepatitis, cirrhosis, short bowel syndrome, or major upper GI surgery
  • Inability to swallow tablets or capsules or expected poor compliance with oral treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

Berkeley Outpatient Center

Berkeley, California, United States, 94158

Actively Recruiting

2

City of Hope -Duarte Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

3

City of Hope - Lennar Foundation Cancer Center

Irvine, California, United States, 92618

Actively Recruiting

4

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

5

UCSF

San Francisco, California, United States, 94158

Actively Recruiting

6

City of Hope

South Pasadena, California, United States, 91030

Actively Recruiting

7

John Muir Health

Walnut Creek, California, United States, 94598

Actively Recruiting

8

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

9

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

10

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

11

Maple Grove Cancer Center

Maple Grove, Minnesota, United States, 55369

Actively Recruiting

12

Hennepin Healthcare -Minneapolis

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

13

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

14

Health Partners - Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States, 55426

Actively Recruiting

15

Health Partners - Regions Hospital

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

16

Englewood Hospital and Medical Center

Englewood, New Jersey, United States, 07631

Actively Recruiting

17

Mount Sinai Union Square

New York, New York, United States, 10003

Actively Recruiting

18

Mount Sinai Chelsea

New York, New York, United States, 10011

Actively Recruiting

19

Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

20

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

21

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Actively Recruiting

22

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

23

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States, 19010

Active, Not Recruiting

24

Paoli Hospital

Paoli, Pennsylvania, United States, 19301

Active, Not Recruiting

25

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19096

Active, Not Recruiting

26

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

27

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

K

Kim Nelson, RN

CONTACT

T

Tammy Neseth, MA, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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