Stage IB Breast Cancer Clinical Trial
Official title:
Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy
Verified date | January 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.
Status | Completed |
Enrollment | 67 |
Est. completion date | May 2021 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-II (including ductal carcinoma in situ), or prophylaxis (breast cancer, early onset [BRCA] mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected) - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) - Total bilirubin < 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2.5 x ULN - Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x ULN - Creatinine < 2 x ULN - Alkaline phosphatase < 2.5 x ULN - Blood urea nitrogen < 2 x ULN - Willing to use non-hormonal contraception (adequate barrier-type contraception or intrauterine device [IUD]) from the time the pregnancy test is performed for the duration of study participation, and 30 days after study drug cessation (for women of childbearing potential only) - Ability to understand and the willingness to sign a written informed consent document - Willing and able to schedule mastectomy 4 weeks (+/- 7days) following start of study agent - Willing to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing - Negative urine pregnancy test result, for participants of child bearing potential, within 5 days prior to first dose of study medication; female of child-bearing potential is any woman (regardless of sexual orientation, whether she has undergone a tubal ligation, or remains celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; OR has had a menstrual period at any time in the preceding 12 consecutive months) - Willing to use alcohol in moderation while taking study agent Exclusion Criteria: - The presence of skin invasion by the breast cancer, or inflammatory changes with skin edema AND erythema. Note: Paget's disease is permitted. - Women receiving a "nipple delay" procedure prior to mastectomy. - Women with skin diseases (psoriasis, eczema) on breast. - A history of thromboembolic disorder or cerebral vascular disease - Use of oral contraceptives or other hormonal treatments within eight weeks prior to the randomization or during the period of the study; women should not have used Depo-Provera in the preceding 6 months; use of hormone coated IUD like Mirena is allowed - Participants may not have received any other investigational agents in the previous 3 months - History of allergic reactions attributed to compounds of similar chemical or biologic composition to telapristone (i.e. other progesterone antagonists) - Taken tamoxifen or other selective estrogen/progesterone receptor modulators (SERMs/SPRMs) within two years prior to entering study or been required to discontinue SERM therapy due to thromboembolic or uterine toxicity - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - History of prior breast cancer-specific therapy within the previous 2 years; previous unilateral radiation in women scheduled for mastectomy of the contralateral side is allowed - Pregnant or breastfeeding - Currently taking spironolactone - Recent history (within 6 months) of alcoholism or drug abuse - Known active infection with human immunodeficiency virus (HIV), hepatitis A, B, or C |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Cedars-Sinai Medical Center | West Hollywood | California |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Levels of Telapristone Acetate in Breast Tissue | Post-therapy mean levels of telapristone acetate in breast tissue. | At the time of mastectomy, up to 5 weeks from baseline | |
Secondary | Plasma Concentrations of Telapristone Acetate | Post-therapy plasma concentrations of telapristone acetate. | At the time of mastectomy, up to 5 weeks from baseline | |
Secondary | Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate | Post-therapy concentrations of telapristone acetate in 5 locations within breast tissue. | At the time of mastectomy, up to 5 weeks from baseline | |
Secondary | Changes in Cell Proliferation | Changes in cell proliferation (Ki67 labeling index) measured in percentage of positive cells from baseline to mastectomy by tumor status in ER positive tumors. | Baseline to mastectomy (up to 5 weeks) | |
Secondary | Changes in Serum Sex Hormone Concentrations: Estradiol | Change in estradiol in premenopausal women from baseline to post-intervention compared between treatment groups | Baseline to mastectomy, up to 5 weeks post-intervention | |
Secondary | Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire | Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced | Baseline to mastectomy (up to 5 weeks) | |
Secondary | Changes in Serum Sex Hormone Concentrations: Progesterone | Change in progesterone in premenopausal women from baseline to post-intervention compared between treatment groups | Baseline to mastectomy (up to 5 weeks) | |
Secondary | Changes in Serum Sex Hormone Concentrations: FSH | Change in FSH in premenopausal women from baseline to post-intervention compared between treatment groups | Baseline to mastectomy (up to 5 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02235051 -
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
|
N/A | |
Completed |
NCT03233555 -
Extended Cancer Education for Longer-Term Survivors in Primary Care for Patients With Stage I-II Breast or Prostate Cancer or Stage I-III Colorectal Cancer
|
N/A | |
Terminated |
NCT02454777 -
High-Intensity Interval Training for Stage I-III Breast Cancer Patients
|
N/A | |
Completed |
NCT03061175 -
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
|
N/A | |
Recruiting |
NCT03156309 -
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
|
Phase 1 | |
Completed |
NCT01928186 -
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
|
N/A | |
Terminated |
NCT01222377 -
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02780401 -
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
|
Phase 1 | |
Terminated |
NCT01409811 -
Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
|
N/A | |
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT01478477 -
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
|
N/A | |
Completed |
NCT01672684 -
Phase I: At-Home Support for Rural Women Using Group Video Calling
|
Phase 1 | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00194779 -
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
|
Phase 2 | |
Recruiting |
NCT02927912 -
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
|
Phase 2 | |
Completed |
NCT02566408 -
Attitudes, Beliefs, and Preferences of Older Stage I-III Breast Cancer Survivors Towards Physical Activity
|
N/A | |
Terminated |
NCT02370264 -
Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer
|
N/A | |
Terminated |
NCT01243541 -
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
|
N/A | |
Completed |
NCT01941784 -
Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy
|
N/A | |
Terminated |
NCT01712815 -
PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer
|
N/A |