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Diindolylmethane in Treating Patients With Breast Cancer

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
StatusTamamlandı
Sponsorlar
University of Arizona
Əməkdaşlar
National Cancer Institute (NCI)

Açar sözlər

Mücərrəd

This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and be an effective treatment for breast cancer.

Təsvir

PRIMARY OBJECTIVES:

I. Assess change in breast density using mammogram-based breast density measures as well as a novel, quantitative fat-water ratio breast magnetic resonance imaging (FWR-MRI).

II. Evaluate the effect of an escalating daily dose of DIM on serum steroid hormones (estrogen, sex hormone binding globulin [SHBG]) and urinary 2-hydroxyestrone:16 alpha-hydroxyestrone (2OHE1:16 alpha OHE1) ratio as well as serum tamoxifen (TAM) metabolites (endoxifen). The study will be initiated at a dose of 75 mg twice daily (BID) (total daily dose of 150 mg) for the first 10 study participants and then the dose will be escalated to 150 mg DIM BID (total daily dose of 300 mg) if no treatment-related serious adverse events (SAEs) are reported in the initial 10 subjects thru 3 months of treatment.

III. Expand on currently available toxicity and safety of DIM-TAM combination by assessing reports of treatment associated side effects/adverse events including TAM-associated endometrial toxicity (self-reported vaginal bleeding patterns and physician ordered vaginal ultrasound), chemistry profiles, Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) scores and standard Common Terminology Criteria for Adverse Events (CTCAE) tracking.

SECONDARY OBJECTIVES:

I. Collect fine-needle aspiration breast tissue samples (in a subset) and blood samples (all participants) in order to explore change in mammary gland tissue architecture and cellularity; and tissue markers and their association with change in breast density and to explore changes in biomarkers of disease risk (e.g. cyclooxygenase-2 [COX-2], deoxyribonucleic acid [DNA] adducts, oxidative stress, inflammation, etc) over time (pre and post treatment) in both study arms.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive diindolylmethane orally (PO) BID for approximately 36 months.

ARM II: Patients receive placebo PO BID for approximately 36 months.

In both arms, treatment continues in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Tarixlər

Son Doğrulandı: 03/31/2016
İlk təqdim: 07/05/2011
Təxmini qeydiyyat təqdim edildi: 07/10/2011
İlk Göndərmə: 07/11/2011
Son Yeniləmə Göndərildi: 10/30/2017
Son Yeniləmə Göndərildi: 11/05/2017
Həqiqi Təhsilin Başlama Tarixi: 01/31/2011
Təxmini İlkin Tamamlanma Tarixi: 08/31/2014
Təxmini İşin Tamamlanma Tarixi: 07/30/2016

Vəziyyət və ya xəstəlik

Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer

Müdaxilə / müalicə

Dietary Supplement: Arm I (antineoplastic therapy)

Dietary Supplement: Arm II (placebo)

Faza

-

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: Arm I (antineoplastic therapy)
Patients receive diindolylmethane (BioResponse) PO BID for approximately 18 months.
Dietary Supplement: Arm I (antineoplastic therapy)
Given PO
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for approximately 18 months.
Dietary Supplement: Arm II (placebo)
Given PO

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 19 Years Üçün 19 Years
Təhsilə Uyğun CinslərFemale
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- Prescribed TAM as adjuvant therapy for early stage (0, I, II, IIIa) breast cancer or as chemoprevention in women at high risk for breast cancer

- New or planned prescription of TAM therapy; ineligible for randomization until on TAM for > 3 months with the expectation to continue use for > 18 months

- Mammogram with Breast Imaging Reporting and Data System (BIRADS) score of >= 2; (equivalent to the following and similar breast density descriptive terms found in mammogram reports: 2 = scattered fibroglandular elements/densities; 3 = heterogeneously dense tissue; 4 = extremely dense tissue)

- No use of soy-based dietary supplements or willingness to discontinue use, complete a 4-week wash-out period, prior to randomization, and refrain from use during trial period

- If pre-menopausal, non-pregnant (confirmed with urinary pregnancy test); practicing birth control or s/p oophorectomy

- Able to complete study run-in activities, including taking study-provided placebo pill twice daily (AM & PM) and recording pill intake and any symptoms experienced on a study calendar, with a compliance rate of at least 80%

- Normal blood chemistry test that includes sodium and specific kidney and liver function tests (creatinine, alanine amino transferase-ALT, aspartate amino transferase-AST) within 30 days of study enrollment; (Informed Consent Form signed)

- No history of hyponatremia

Nəticə

İlkin nəticə tədbirləri

1. Urinary 2OHE1:16alpha OHE1 ratio [Up to 18 months]

estrogen metabolites measured in ng/100ul; this outcome will also be reported as a ratio

İkincili Nəticə Tədbirləri

1. Plasma TAM metabolites (ng/mL) [Up to 18 months]

measures of 4 primary metabolites (UCSF)

2. Serum Estrogen (estradiol) (pg/mL) [Up to 18 months]

measured at U Michigan

3. Self reported vaginal bleeding [Up to 24 months]

If vaginal ultrasound is available via medical records, toxicity will be addressed through endometrial evaluation. Otherwise, evaluation will be based on self report.

4. mammographic density [up to 18 months]

assessed by fat:water ratio magnetic resonance imaging AND mammographic density from clinical mammograms

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