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New treatment option for Ductal Carcinoma in Situ
Official title DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
ClinicalTrials.gov ID: NCT06075953
What this study is testing
What is Tamoxifen?
Tamoxifen is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ductal carcinoma in situ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- A. Female, at least 18 years old B. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis)...
- Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to...
You likely can't join if
- A. Pregnant or actively breastfeeding women
- B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical...
- C. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
- D. Co-enrollment in clinical trials of pharmacologic agents requiring an IND
- E. Ongoing treatment for DCIS other than what is specified in this protocol
- F. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements
See the full eligibility criteria
- A. Female, at least 18 years old B. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion
- Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial. C. Patients who have previously received endocrine...
- A. Pregnant or actively breastfeeding women
- B. 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
- C. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
- D. Co-enrollment in clinical trials of pharmacologic agents requiring an IND
- E. Ongoing treatment for DCIS other than what is specified in this protocol
- F. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements
- G. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis...
- \ Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C...
- H. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment
- I. Participants with substantial MRI artifacts (e.g., related to localizer sequences, cardiac devices such as pacemakers, or other hardware) that render the lesion non-evaluable.
- J. Severe allergy or reaction history to MRI contrast.
- K. Participants currently undergoing or who have received treatment for another malignancy within the previous 6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Berkeley, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- South Pasadena, California, United States
- Walnut Creek, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Maple Grove, Minnesota, United States
- Minneapolis, Minnesota, United States
- Saint Louis Park, Minnesota, United States
- Saint Paul, Minnesota, United States
- Englewood, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Bryn Mawr, Pennsylvania, United States
- Paoli, Pennsylvania, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berkeley, California, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; San Francisco, California, United States; South Pasadena, California, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.