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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06075953
Trial Phases:	Phase II	Protocol IDs:	RECAST-DCIS (primary) NCI-2023-10907
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	QuantumLeap Healthcare Collaborative
NCI Full Details:	http://clinicaltrials.gov/show/NCT06075953

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.

Objectives

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. The current management of most
patients with DCIS involves surgical intervention with or without radiation, similar to
more aggressive breast cancers. These treatments can come with some significant health
effects.The main question this study aims to answer is: to determine whether novel
endocrine therapy increases the fraction of patients who will be suitable for long-term
active surveillance.

Participants will be asked to take one of three investigational study medication
(z-Elacestrant, Testosterone + Anastrazole, or Endoxifen) or receive control hormonal
therapy (Tamoxifen or an aromatase inhibitor), depending on the treatment to which they
have been randomized. 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, with follow up evaluations of Mammogram and MRI at 6
month intervals. 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.

Participants will be followed annually for 10 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.