Cancer Prevention Clinical Trials

Alternative Dosing of Exemestane in Postmenopausal Women with Stage 0-II ER-Positive Breast Cancer: A Randomized Pre-surgical Trial

Principal Investigator:  

Status:  

Population:  Female patients with a history of histologically confirmed ER-positive primary breast cancers who are candidates for breast surgery.

Eligible:

• Postmenopausal women < 75 years of age with histologically confirmed ER-positive primary breast cancer stage T0-2, N0-1, Mx . 
• Must refuse chemo and/or endocrine neo-adjuvant therapy.  

Ineligible:

• BMI < 18.5
• Previous treatment for breast cancer including chemotherapy and endocrine therapy.
• Other co-existing malignancies diagnosed during the last 2 years before randomization (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma).
• History of severe osteoporosis or presence of vertebral fracture.
• Use of Hormone Replacement Therapy 30 days prior to randomization
• Use of any chemopreventative agents (SERM) in the last 3 months.

Brief Description:

Exemestane has been approved as one of the treatments for breast cancer in postmenopausal women. It can be used after breast cancer recurrence or as first treatment after surgery. This study will address the effect of Exemsestane given at a different schedule compared to standard dose. The goal of this research study is to test whether giving Exemestane less often than every day can lower hormone levels as much as giving the drug daily and cause similar changes in breast cancers with fewer side effects.

Phase: II

Study Contacts:  Diane Weber, RN, 713-563-5752

A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients with a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease

Principal Investigator:  Powel Brown, M.D., Ph.D.

Status:  Closed to new patient accrual

Population:  Female patients with a history of histologically confirmed breast cancer, premalignant lesions or benign breast disease with a Body Mass Index > 25.

Eligible:

• Female patients > 18 years of age, irrespective of menopausal status. 
• Patients who are overweight or obese; BMI > 25
• Patients who are at least six months since any breast cancer treatment and have no evidence of breast cancer at study entry.

Ineligible:

• Patients with any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months.
• Patients with a history of histologically-confirmed bilateral invasive breast cancer.
• Patients with bilateral implants or those who have had bilateral mastectomies.
• Patients with a history of prior radiation therapy to the unaffected breast.
• Patients who are pregnant.        

Brief Description:

The goal of this research study is to determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000mg twice daily as compared to placebo reduces normal breast tissue levels of TNF-α in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget’s disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.

Phase: II

Study Contacts: Diane Weber, RN,  713-563-5752; Carrie Mays, RN,  713-563-2055

NCT01849250                     

Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction:  A Phase IIB Randomized Placebo-Controlled Trial

Principal Investigator:  Therese B. Bevers, M.D.

Status:  Open to new patient accrual

Population:  Female patients > 25 years old who have a history of receiving mantle radiation for childhood, adolescent, or young adult cancers prior to the age of 40. 

Eligible:

• Patients who are female > 25 years old
• Patients with a history of childhood, adolescent, or young adult cancers more than 2 years ago
• Patients who received mantle radiation treatment for their cancer, before the age of 40
• Patients who are well defined as pre- or post-menopausal

Ineligible:

• Patients on current hormone therapy or oral contraceptives.
• Patients with bilateral implants or mastectomy.
• Patients with a history of DVT

Brief Description:

The goal of this clinical research study is to learn if 2 years of low-dose tamoxifen can help to prevent breast cancer in patients who have had cancer and received radiation therapy to the chest. The safety of this drug will also be studied. In this study, tamoxifen will be compared to placebo. A placebo is not a drug. It looks like the study drug, but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Phase: IIB

Study Contact:  Diane Weber, RN, 713-563-5752; Carrie Mays, RN, 713-563-2055

NCT01196936

Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Meformin Chemoprevention versus Placebo Control in Premenopausal Women

Principal Investigator:  Therese B. Bevers, M.D.

Status:  Open to new patient accrual

Population:  Premenopausal women with a prior biopsy containing ALH, ADH, LCIS or DCIS and a mammographic breast density of > 25%.

Eligible:

• Female patients age 25-55 years old and pre-menopausal
• Patients with a mammographic density > 25%; and a Body Mass Index > 25
• Patients with a prior biopsy demonstrating ALH, ADH, LCIS or DCIS; or a Gail Model Risk of > 1.66% over 5 years; or known BRCA1 or BRCA 2 mutations.      

Ineligible:

• Patients with other active malignancies < 5 years, except for non-melanotic skin cancer or carcinoma-in-situ of the cervix
• Patients with bilateral breast implants or autologous breast flap reconstruction
• Patients receiving tamoxifen or raloxifene

Brief Description:

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (marker of breast cancer risk) in women at increased risk for breast cancer. We will test for the presence or absence of cytological atypia in RPFNA bilateral aspirates after 12 and 24 months (24 month is optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) for women receiving metformin versus placebo control.

Phase:

Study Contacts: Diane Weber, RN, 713-563-5752; Carrie Mays, RN, 713-563-2055
NCT01905046

Repository of Tissue, Blood and Saliva on Patients in the Cancer Prevention Center (aka High Risk Breast Cohort)

Principal Investigator:  Abenaa Brewster, M.D.

Status:  Open to new patient accrual

Population:  Female patients with a 5 year risk of > 1.66 or > 20% risk of breast cancer as determined by Gail, Clause, Tyrer-Cuzick, IBS models, OR a personal diagnosis of ADH, ALH, LCIS, DCIS, BRCA 1 or BRCA 2, OR a history of Mantle radiation treatment.

Eligible:

• Female patients > 18 years old
• Patients with a with a modified Gail Model risk at 5 years of > 1.66%  or a lifetime risk  > 20% of breast cancer as determined by Gail, Clause, Tyrer-Cuzick, IBS models, OR
• Patients who have had a diagnosis of proliferative benign breast disease such as ADH, ALH, LCIS or DCIS, OR
• Patients with a known deleterious mutation in BRCA 1 or BRCA2, OR
• Patients who have received mantle radiation treatment for a cancer at < 30 years of age              

Ineligible:

• Patients with a history of invasive breast cancer
• Patients with a history of previous malignancy and treatment within the past 5 years, excluding cervical in-situ or non-melanoma skin cancer
• Patients with prior bilateral mastectomies
• Patients who are unable or unwilling to complete follow-up questionnaires and provide repeat blood samples

Brief Description:

The goal of this research study is to collect biological samples (blood) and clinical information from patients seen in the Cancer Prevention Center, annually for 10 years. Researchers will also store the samples in a research tissue/blood bank and the information in a research database for use in future research related to cancer. 

Study Contacts: Sandy Black, 713-745-5434; Rolanda Moses,  713-745-4389

High-Intensity Interval Training for Women at Heighted Risk for Breast Cancer

Principal Investigator: Susan Lakoski, M.D., M.S.

Status: Preparing for activation

Population:  Overweight or obese perimenopausal women at high risk of developing breast cancer who are enrolled in the Longitudinal High Risk Cohort study within the Cancer Prevention Center at MD Anderson.

Eligible:

• Perimenopausal at the time of enrollment
• At high risk of developing breast cancer (history of DCIS, LCIS, ADH, or Gail 5 year risk >1.66% or lifetime risk >20%)
• BMI > 25 kg/m2
• Willing to perform supervised exercise training 3 times a week for 3 months

Ineligible:

• Underlying medical problems that contraindicate exercise
• Lives outside the greater Houston area (Harris and contiguous counties)
• Pregnant
• On risk reduction therapy with Tamoxifen

Brief Description:

Rationale is to examine exercise as a non-pharmacological strategy to prevent invasive breast cancer.  The goal of this study is to determine whether high-intensity interval exercise offsets the tumor promoting effects of obesity during a critical window of breast cancer susceptibility.  High-intensity exercise will be compared to moderate continuous exercise or usual care in high-risk cancer patients.

Study Contact: Adrianna Coletta, 713-745-0338

A Phase Ib Biomarker Trial of Naproxen in Patients at Risk for DNA Mismatch Repair Deficient Colorectal Cancer

Principal Investigator:  Eduardo Vilas-Sanchez, M.D., Ph.D.

Status:  Open to new patient accrual

Population:  Patients at risk for DNA Mismatch Repair Deficient Colorectal Cancer as defined as: (1) Mutation Positive Lynch Syndrome, or (2) Mutation Negative Lynch Syndrome

Eligible:

• Patients > 18 years of age with a confirmed history of Lynch Syndrome.
• Patients with no evidence of cancer or cancer treatment in the past 6 months.
• Patients must be at least 6 months from any prior cancer-directed treatment.
• Patients must have endoscopically accessible distal colon and/or rectal mucosa.   

Ineligible:

• Patients who are status post total proctocolectomy.
• Patients with active gastroduodenal ulcer disease in the preceding 5 years.
• Patients with any history of transfusion-dependent gastrointestinal bleeding, perforation or obstruction.
• Patients taking concomitant NSAIDs, aspirin, COX-2 inhibitors, SSRIs, Anticoagulants, other investigational agents.

Brief Description:

To determine whether treatment with Naproxen at a once-daily 220 mg or 440 mg dose, administered for 6 months as compared to placebo reduces the concentration of Prostaglandin E3 (PGE2) levels in normal colorectal mucosa in subjects at risk for a mismatch repair deficient colorectal cancer.

Phase: Ib

Study Contacts: Valerie Sepeda, RN, 713-745-3670

NCT02052908

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer

Principal Investigator:  Elise D. Cook, M.D.

Status:  Open to new patient accrual

Population:  Patients with a history of Stage 0-III Colon or Rectal cancer who are 6-15 months from their primary resection and have completed all recommended treatment with no evidence of disease.  Study therapy is 36 months.

Eligible:

• Patients > 18 years of age.
• Patients with a history of Stage 0-III colon or rectal cancer who are 6-15 months from their primary resection.
• Patients who have completed Adjuvant chemotherapy and RT treatment at least 30 days prior to registration.
• Patients must show no evidence of disease.
• Patients must have must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration.        

Ineligible:

• Patients may not take any concomitant NSAIDs, Anticoagulants or Corticosteroids while on study.
• Patients may not have any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease free for > 5 years.

Brief Description:

The goal of this clinical research study is to learn if taking eflonithine and/or sulindac (possibly with a placebo) can help to prevent growths in the colon or rectum that may lead to colorectal cancer, as well as the growth of a new colorectal cancer, in patients who have already been treated for colon or rectal cancer (up to Stage III).

Phase: III

Study Contact: Valerie Sepeda, RN, 713-745-3670

NCT01349881                                

A Randomized Phase II Trial of Low Dose Aspirin versus Placebo in High-Risk Individuals with CT Screen Detected Subsolid Lung Nodules

Principal Investigator:  Therese B. Bevers, M.D.

Status:  Open to new patient accrual

Population:  Men and women, current or former smokers, with undetermined subsolid lung nodules confirmed by a low dose screening CT scan. 

Eligible:

• Age > 50 years old
• Low dose CT Scan confirming persistent subsolid nodules who are not a candidate for surgical excision.
• Asymptomatic current or former smokers (having stopped within the last 20 years).  All current smokers should accept to receive support for smoking cessation.
• Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.

Ineligible:

• Subjects with chronic treatment (at least twice/week for more than 3 months) with Aspirin or other NSAIDs.
• Invasive malignancy diagnosed during the last 2 years before randomization (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma)
• History of therapeutic doses of anticoagulants in the preceding year.

Brief Description:

The purpose of this study is to compare the safety and effects of low dose aspirin (100mg/day) with placebo on subjects with subsolid nodules. The primary objective is the evaluation of the effect of Aspirin as a chemopreventative agent for lung cancer.

Phase: II

Study Contact: Diane Weber, RN, 713-563-5752

NCT02169271