Topical Calcipotriene Treatment for Breast Cancer Immunoprevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03596073|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : November 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Topical Calcipotriene Ointment Other: Topical Vaseline||Phase 1|
The investigators are doing this research study to find out how topical calcipotriene ointment affect people who have breast cancer, and what impact that may have on those who are at risk of developing breast cancer in the future. The investigators hope that what they learn will lead to the development of a new medication for the treatment and prevention of breast cancer.
Abnormal breast lesions can be benign, premalignant or malignant. These lesions are being targeted by the topical calcipotriene ointment. The investigators aim to determine whether this topical treatment can stimulate the immune cells against the breast lesion in ways that would prevent its recurrence after surgical removal.
Calcipotriene ointment is approved by the U.S. Food and Drug Administration (FDA) to treat psoriasis, but calcipotriene ointment is not approved by the FDA to treat breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Pilot Trial of Topical Calcipotriene Treatment for Breast Cancer Immunoprevention|
|Actual Study Start Date :||November 7, 2018|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2024|
Experimental: Topical Calcipotriene Ointment
-Topical Calcipotriene Ointment will be administered by the participants to their upper extremities twice a day for the period between core biopsy and surgical removal of their breast lesion
Drug: Topical Calcipotriene Ointment
Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.
Placebo Comparator: Topical Vaseline
-Topical Vaseline will be administered by the participants to their upper extremities twice a day for the period between core biopsy and surgical removal of their breast lesion
Other: Topical Vaseline
- The changes in the magnitude of CD3+ T cell infiltration in tumor microenvironment [ Time Frame: 3 Weeks ]The change in the number of CD3+ T cells per high power microscope field in tumor microenvironment from the time of initial needle core biopsy to surgical excision.
- The comprehensive changes in tumor immune microenvironment [ Time Frame: 3 Weeks ]
- The changes in tumor immune microenvironment in patients with neoplastic tumors versus benign lesions [ Time Frame: 3 Weeks ]
- The changes in tumor immune microenvironment in patients with stage I-II, versus stage 0 tumors [ Time Frame: 3 Weeks ]
- The changes in tumor immune microenvironment in patients with hormone receptor and Her2 positive versus triple negative tumors [ Time Frame: 3 Weeks ]
- Serum Serum Thymic Stromal Lymphopoietin (TSLP) levels (picogram/milliliter) before and after topical calcipotriene treatment compared to Vaseline control group [ Time Frame: 3 Weeks ]
- Disease free survival [ Time Frame: From the start of treatment up to 15 years ]The duration of time measured from the start of treatment until the time of disease progression or death, whichever occurs first.
- Number of Participants with Treatment Related Adverse Events [ Time Frame: From the start of treatment until 30 days after the end of treatment, up to 2 months ]Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v4).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596073
|Contact: Shadmehr Demehri, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Shadmehr Demehri, MD 617-643-6436 firstname.lastname@example.org|
|Principal Investigator: Shadmehr Demehri, MD|
|Principal Investigator:||Shadmehr Demehri, MD||Massachusetts General Hospital|