DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
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.
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.
Breast
Phase II
Adults
Chemoprevention,
Hormonal Therapy
Not Available
Meszoely, Ingrid
National
Vanderbilt University
10-28-2024
Eligibility
18 Years
FEMALE
NO
Inclusion 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
Exclusion Criteria:
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.
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
Exclusion Criteria:
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.
