Trial Title:
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
NCT ID:
NCT06075953
Condition:
Ductal Carcinoma in Situ
Conditions: Official terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Tamoxifen
Letrozole
Exemestane
Anastrozole
Testosterone
Conditions: Keywords:
active surveillance
hormone therapy
endocrine therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
RECAST-DCIS is an open-label, multi-site platform study designed to offer women with
Ductal cell Carcinoma In Situ (DCIS) 6 months of neo-adjuvant exposure to endocrine
therapy with the intent of determining their suitability for long-term active
surveillance without surgery.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
For premenopausal women: 20 mg or 5 mg tamoxifen orally for postmenopausal women: For
postmenopausal women who are not tolerating an AI, investigators can change them to the
low dose (5 mg) or standard dose (20 mg) of tamoxifen
Arm group label:
chemoprevention therapy per investigator choice
Intervention type:
Drug
Intervention name:
Exemestane
Description:
for postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, or
reduced exemestane dosing: 25 mg 3 times per week orally
Arm group label:
chemoprevention therapy per investigator choice
Intervention type:
Drug
Intervention name:
Letrozole
Description:
for postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily,
Arm group label:
chemoprevention therapy per investigator choice
Intervention type:
Drug
Intervention name:
Anastrazole
Description:
for postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily;
Arm group label:
chemoprevention therapy per investigator choice
Intervention type:
Drug
Intervention name:
Testosterone + Anastrazole
Description:
Investigational drug. Both pre- and post- menopausal subjects. 100mg testosterone in
combination with 4mg anastrazole administered subcutaneously every 3 months for up to 3
years.
Arm group label:
Testosterone + Anastrazole (T+Ai)
Other name:
T+Ai
Intervention type:
Drug
Intervention name:
Elacestrant
Description:
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with
food once daily up to 36 months.
Arm group label:
Elacestrant
Intervention type:
Drug
Intervention name:
Z-endoxifen
Description:
Investigational drug. Both pre- and post- menopausal subjects. (z)-endoxifen 10mg delayed
release capsule 1 hour before a meal or 2 hours after a meal once daily for up to 36
months.
Arm group label:
Endoxifen
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.
Detailed 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. 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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Berkeley Outpatient Center
Address:
City:
Berkeley
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Niloufar Abdollahi
Phone:
415-476-3322
Email:
Niloufar.abdollahi@ucsf.edu
Contact backup:
Last name:
Cristian Maldonado-Rodas
Phone:
415-502-8545
Email:
cristian.maldonadorodas@ucsf.edu
Investigator:
Last name:
Laura Esserman, MD
Email:
Principal Investigator
Facility:
Name:
UCSF
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cristian Maldonado-Rodas
Phone:
415-502-8545
Email:
Cristian.MaldonadoRodas@ucsf.edu
Contact backup:
Last name:
Lorraine Jiang
Phone:
310-962-0727
Email:
lorraine.jiang@ucsf.edu
Investigator:
Last name:
Laura Esserman, MD
Email:
Principal Investigator
Facility:
Name:
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jenna Littel, RN
Phone:
336-716-0484
Email:
j.littell@wakehealth.edu
Contact backup:
Last name:
Jonae Wyche
Phone:
336-716-9997
Email:
jwyche@wakehealth.edu
Investigator:
Last name:
Marissa Howard-McNatt, MD
Email:
Principal Investigator
Facility:
Name:
Bryn Mawr Hospital
Address:
City:
Bryn Mawr
Zip:
19010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Burrell
Phone:
484-476-2649
Email:
burrellje@mlhs.org
Investigator:
Last name:
Paul Gilman, MD
Email:
Principal Investigator
Facility:
Name:
Riddle Hospital
Address:
City:
Media
Zip:
19063
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Burrell
Phone:
484-476-2649
Email:
burrellje@mlhs.org
Contact backup:
Last name:
Alison Keenan
Phone:
484.476.2379
Email:
KeenanA@mhs.org
Investigator:
Last name:
Paul Gilman, MD
Email:
Principal Investigator
Facility:
Name:
Paoli Hospital
Address:
City:
Paoli
Zip:
19301
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Burrell
Phone:
484-476-2649
Email:
burrellje@mlhs.org
Investigator:
Last name:
Paul Gilman, MD
Email:
Principal Investigator
Facility:
Name:
Lankenau Medical Center
Address:
City:
Wynnewood
Zip:
19096
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Burrell
Phone:
484-476-2649
Email:
BurrellJe@mlhs.org
Contact backup:
Last name:
Shruti Yerramothu
Email:
yerramothus@mlhs.org
Investigator:
Last name:
Paul Gilman, MD
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Oncology nursing
Phone:
800-811-8480
Email:
cip@vumc.org
Contact backup:
Last name:
Denise W King
Phone:
615.875.7722
Email:
Denise.w.king@vumc.org
Investigator:
Last name:
Rachel McCaffrey, MD
Email:
Principal Investigator
Start date:
February 14, 2024
Completion date:
November 2033
Lead sponsor:
Agency:
QuantumLeap Healthcare Collaborative
Agency class:
Other
Source:
QuantumLeap Healthcare Collaborative
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075953
