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Clinical Trial

Breast, Omega 3 Free Fatty Acid, Ph 0

Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily)

Clinical Trial

Aging Mammary Stem Cells and Breast Cancer Prevention

Leftover breast biopsy and surgical tissues from DCIS patients at 60 years of age will be used for studying the effect of aging on the properties of human MaSCs. A randomized case-control study will be carried out for testing if seven-day rapamycin treatment can reduce malignant markers and MaSC number.

Clinical Trial

Improving Adherence to EHT Among Breast Cancer Patients

Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces cancer recurrence rates and cuts the risk of death nearly in half during the second decade after diagnosis, research shows. Despite the proven benefits, about 33% of women who are prescribed EHT do not take their medication as prescribed (less than 80% take their daily dosage) and are thus at higher risk of recurrence and death. This educational randomized controlled study will develop and pilot-test a bilingual, culturally tailored, personalized, interactive mobile application (app) in combination with patient navigation to promote and improve adherence to endocrine hormonal therapy (EHT) among breast cancer patients.

Clinical Trial

Olive Oil for High Risk Breast Cancer Prevention in Women

This is a single-arm, pilot breast cancer prevention study of hydroxytyrosol in women at increased risk of breast cancer. Our primary study endpoint will be defined as proportion of women who exhibit a 10% absolute reduction in mammographic density at one-year of follow-up (Cuzick JNCI 2011). For each of the post and pre-menopausal group of women, we will assume under the null hypothesis that 25% of women will exhibit a response (at least a 25% reduction from baseline) versus an alternative hypothesis equal to 45% based on data presented from Cuzick (JNCI 2011). Under these assumptions, a sample of 50 pre-menopausal and 50 post-menopausal women will provide 85% power based on a two-sided test for a single proportion with 5% significance level for each group of women.

Clinical Trial

S-equol in Women With Triple Negative Breast Cancer

This will be a single arm, non-randomized phase II clinical trial of women with newly diagnosed triple negative breast cancer. After having a core needle biopsy of the breast confirming triple negative breast cancer, eligible women enrolled on the study will be treated with S-equol at a dose of 50 mg PO twice daily for 10-21 days. Appropriate patients will be offered the study at their first clinic visits with medical oncology. Patients will be issued the drug and will start taking the drug the day they sign consent. During this treatment period, patients will continue with routine pre-operative planning and evaluations. This study will not delay patients proceeding to surgical intervention. Patients will continue on S-equol until the day of their surgery, which is anticipated to be about 14 days. Since the time from diagnosis to surgery varies slightly between patients, we will aim for 14 days of treatment, but will include women who receive treatment for at least 10 days and up to 21 days in our analysis. This ensures that we do not delay proceeding with standard of care treatment for early stage breast cancer which is surgical resection and ensures that we do not stop S-equol days prior to surgical resection. Patients will be evaluated the day of surgery (between day 10-21) for toxicity check and drug return. If patients are not expected to have surgery, such as those with inoperable, metastatic disease or needing neoadjuvant chemotherapy with the aim of breast conservation, a repeat core needle biopsy will be conducted in the medical oncology clinic on day 14. Patients will then be re-evaluated in the medical oncology clinic on day 42 as part of a routine post-surgical or treatment follow up appointment with repeat physical exam, toxicity check and routine laboratory testing to evaluate for any toxicity to S-equol. We do not anticipate any additional or extra visits to the clinic in order to participate in this study.

Clinical Trial

Breast Cancer WEight Loss Study (BWEL Study)

This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms: a telephone-based intervention group and a health education control group. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other).

Clinical Trial

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

Clinical Trial

Genetic Epidemiology of Breast and Ovarian Cancers

A research study about factors that might increase the chance of getting breast and ovarian cancers. Eligible: female 18-80 yr old; diagnosed with breast cancer under age 50; diagnosed with ovarian cancer at any age; strong family history of breast and/or ovarian cancer.