Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Hormones

Aspirin

Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.

Screening Mammography

Biospecimen Collection

Marie Wood, MD

This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.

PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502.

SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502.

OUTLINE:

Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.

After completion of study, participants are followed up annually until 10 years from registration to study A011502.

Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion Study to Alliance Study A011502

The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline.

The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) \>= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level.

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.

Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

Broccoli Sprout Extract

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Jessica Young

This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.

PRIMARY OBJECTIVES:

I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.

II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).

III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.

IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.

SECONDARY OBJECTIVES:

I. To determine tolerability of ITC-BSE and compliance in breast cancer patients.

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

ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.

ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

After completion of study treatment, patients are followed up at 30 days.

Broccoli Sprout Extract in Treating Patients With Breast Cancer

A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer

Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.

Roswell Park Cancer Institute

Triple Negative Breast Neoplasms

Antineoplastic Agents

Amino Acids

Estrogens

Lapatinib

Progesterone

Veliparib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Tyrosine

Lapatinib will be administered as a tablet at a dosage of 1250 mg/day continuously for 28 days starting on Day 1 of each cycle. Veliparib will be administered as a capsule at a dosage of 200 mg every 12 hours for 28 days starting on Day 2 of each cycle. A cycle of therapy is defined as 28 days. Treatment is administered on an outpatient basis. Patient response will be evaluated every 8 weeks according to the current Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and performance of relevant scans and/or x-rays.

Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.

Combination of Veliparib + Lapatinib

Andres Forero, MD

This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer that have undergone previous treatment. Veliparib is an investigational drug and has not been approved by the FDA while Lapatinib has been approved by the FDA for another type of breast cancer. All eligible participants will receive the study medications and not a placebo.

Breast cancer is the most commonly diagnosed cancer in American women. Metastatic breast cancer remains incurable partially due to the lack of targeted therapy for selected subsets of patients. There are five distinct subsets of breast cancer with unique biological profiles. Triple negative breast cancer (TNBC) is a subset with special clinical interest because of its significant percentage of occurrence (10-20% of all breast cancer diagnoses) and its poor prognosis. With no defined targeted therapy to date, this study seeks to investigate a therapeutic strategy based on specific molecular abnormalities in the tumor cells of TNBC.

Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer

An Open Label, Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer

Drug related toxicities for the safety analysis are defined as: a) any grade 3 or 4 non-hematologic toxicity except alopecia and nausea which is not refractory to anti-emetics; b) failure to recover to baseline (except alopecia) after delaying the next dose by more than 14 days; c) grade 3 or 4 neutropenia complicated by fever equal to or greater than 38.50 degrees C or infection, or grade 4 neutropenia of a least 7 days duration; or d) grade 4 thrombocytopenia, or grade 3 thrombocytopenia complicated by hemorrhage. Toxicity evaluation of the patients enrolled in the trial will be done using the NCI Common Toxicity Criteria.

Complete responses plus partial responses will be included as indicators of an objective response rates.

Number of subjects who survive to 4 years with no disease progression

Analysis of the genomic data from tumors may allow us to identify if there is a gene or groups of genes that will be able to predict response or resistance to the research combination; in order to conduct the genomic evaluation it is necessary to correlate with clinical response. In addition, we will conduct IHC studies in order to analyze markers that will indicate us if the combination of the research agents inhibit the targets for which they were designed (H2AX, BRCA and EGFR); this data needs to be correlated with clinical data to see if the lab evaluations correlate with the response of the patient. In addition, we will evaluate by IHC markers of apoptosis that will indicate us if the combination of research agents was cytotoxic against the tumor cells ; this data needs to be correlated with clinical data to see if the lab evaluations correlate with the response of the patient.

Circulating tumor cells will be measured before and after therapy and will indicate if the therapy is active against the tumor; a decrease in the number of the circulating tumor cells will indicate effectiveness of the combination.

Blood samples for the first day will be collected 5 minutes before the start of therapy, 30 and 60 minutes after the first dose of Lapatinib and then 2, 4, 6, 8, and 24 hours after the start of Lapatinib. On day 2, Lapatinib and Veliparib will be given and samples will be taken 30 and 60 minutes after the first dose and then at 2, 4, 6, 8, and 24 hours. Additional blood samples will be taken on day 3, before the third day dose of the combined study drugs. The same schema will be followed on days 8, 9, and 10.

Each pharmacokinetic variable will be divided by dose groups for descriptive statistical analyses (mean, standard deviation, coefficient of variation, geometric mean, median, minimum and maximum per dose group).

Serum levels of the apoptosis protein M30 will be measured before and after therapy and will indicate if the therapy is active against the tumor; an increase in the level of M30 will indicate effectiveness of the combination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502	NCT03609021	Breast Carcinom... Estrogen Recept... Progesterone Re...	Screening Mammo... Biospecimen Col...	-	Alliance for Clinical Trials in Oncology
Broccoli Sprout Extract in Treating Patients With Breast Cancer	NCT01753908	Ductal Breast C... Ductal Breast C... Estrogen Recept... Estrogen Recept... Invasive Breast... Lobular Breast ... Postmenopausal Stage IA Breast... Stage IB Breast... Stage IIA Breas... Stage IIB Breas...	Broccoli Sprout... Laboratory Biom... Pharmacological... Placebo	21 Years -	Roswell Park Cancer Institute
Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer	NCT02158507	Metastatic Trip...	Combination of ...	19 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for estrogen receptor negative