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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study

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

Condition
Ductal Carcinoma in Situ
Intervention / Treatment

-

Contacts and Locations

Berkeley

Berkeley Outpatient Center, Berkeley, California, United States, 94158

San Francisco

UCSF, San Francisco, California, United States, 94158

Winston-Salem

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States, 27157

Bryn Mawr

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States, 19010

Media

Riddle Hospital, Media, Pennsylvania, United States, 19063

Paoli

Paoli Hospital, Paoli, Pennsylvania, United States, 19301

Wynnewood

Lankenau Medical Center, Wynnewood, Pennsylvania, United States, 19096

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female, at least 18 years old
  • * previous diagnosis of Hormone Receptor positive (HR+) DCIS (at least 50% ER or PR and 2+; biopsy will have been performed previously at diagnosis) with or without microinvasion
  • * Informed consent provided by the patient
  • * Willingness and ability to provide tumor samples for research
  • * Pregnant or actively breastfeeding women (must be documented by a pregnancy test during screening)
  • * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history.
  • * Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
  • * Co-enrollment in clinical trials of pharmacologic agents requiring an Investigational new Drug Appilcation (IND)
  • * Ongoing treatment for DCIS other than what is specified in this protocol
  • * Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements.
  • * Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Participants unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance to oral treatment. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A/B/C\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

QuantumLeap Healthcare Collaborative,

Study Record Dates

2033-11