Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Lobular

Carcinoma, Intraductal, Noninfiltrating

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Hormones

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Tamoxifen 10 mg (1 tablet) every other day for 6 months.

Tamoxifen 10 mg (1 tablet) every other day for 6 months + 5:2 diet (5 days/week at regular energy intake+2 days a week at an average 75% energy deficit)

Step counter device + 5:2 diet (5 days/week at regular energy intake+2 days a week at an average 75% energy deficit)

One tablet of Tamoxifen 10 mg every other day for 6 months

Tamoxifen 10 mg Tablet

"5:2 diet": 5 days a week at regular energy intake and 2 days/week at 75% energy deficit (diet will be restricted at 500-800 kcal corresponding to a 75% reduction compared to normal size)

Intermittent caloric restriction

Participants will receive personal advice on healthy lifestyle and a step counter

Step counter Device

Bernardo Bonanni, MD

Aliana Guerrieri-Gonzaga, MSc

Andrea DeCensi, MD

Matilde Pensabene, MD

Stefania Zovato, MD

Circulating levels of Sex Hormone Binding Globulin (SHBG) are significantly associated with a decreased risk of breast cancer.

The main aim of this clinical trial is to verify whether Low Dose Tamoxifen (LDT) increases circulating levels of SHBG more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months in women at increased risk of breast cancer (i.e., healthy participants carriers of a germline pathogenic/likely pathogenetic variant in at least one of the following genes: BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C or RAD51D, or with \> 5% breast cancer risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast (IEN).

The secondary aims are:

* to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment (HOMA) index, immune and inflammatory markers, lipid profile, Adiponectin/Leptin (A/L) ratio, quality of life (QoL), Body mass index (BMI), fat body composition, safety and toxicity;
* to verify whether LDT significantly modulates secondary endpoints, such as HOMA-index, immune and inflammatory markers, lipid profile, A/L ratio, QoL, BMI, fat body composition, safety and toxicity;
* to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers, cytokines, immune modulators, and inflammatory proteins in serum;
* to investigate MD (Mammographic Breast Density) changes by LDT vs. LI, with or without ICR. This aim will be performed in a subgroup of participants (not all the participants will undergo mammography due to younger age).

Italian, multicenter, phase II, biomarker trial. A total of 200 women aged 18-70 years will be randomly assigned (1:1:1:1) to one of the four intervention arms Arm 1: Low dose Tamoxifen (LDT) i.e. 10 mg every other day; Arm 2: Low dose Tamoxifen (LDT) + Intermittent Caloric Restriction (ICR); Arm 3: Lifestyle intervention (LI) using a step counter; Arm 4: Lifestyle intervention (LI) using a step counter + Intermittent Caloric Restriction (ICR).

Participants will be stratified by center and by disease status (high risk vs. previous IEN) and intervention will last six months for all arms.

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion: a Randomized Phase II Biomarker Trial in Subjects at Increased Risk

Sex hormone binding globulin level after 6 months of intervention

Ente Ospedaliero Ospedali Galliera

Istituto Oncologico Veneto IRCCS

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

European Institute of Oncology

Symptoms and General Pathology

Rare Diseases

Cicatrix

Papilloma

Hyperplasia

Fibroadenoma

Neoplasms, Squamous Cell

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Phyllodes Tumor of the Breast

Patients will undergo vacuum-assisted percutaneous excision (VAPE). The intervention group will have post-procedure imaging the same day to confirm complete excision.

The intervention group will then have imaging at 6, 12, and 24 months as per the radiology algorithms for following suspicious lesions (BIRADS 3 category). If at any point during the imaging follow up, a suspicious lesion or calcifications are detected, it would be sampled with core needle biopsy and then surgically excised as appropriate.

The intervention group will also be seen in clinic at 1 month with no imaging and then at 6, 12, and 24 months to correspond to the imaging visits.

Patients will undergo standard open surgical excision.

The control group will then have follow up imaging at 12 and 24 months as per the usual radiology algorithms following excision of a lesion. If at any point during the imaging follow up, a suspicious lesion or calcifications are detected, it would be sampled with core needle biopsy and then surgically excised as appropriate.

The control group will also be seen in clinic at 1 month with no imaging and then at 12 and 24 months to correspond to the imaging visits.

The intervention group will undergo the vacuum assisted percutaneous excision (VAPE). All VAPE procedures will be performed on a digital supine table using the ATEC© Breast Biopsy System hand piece (Hologic) with a 9-gauge needle and a 10 or 20 mm aperture providing 6-mmHg of suction strength to completely excise the breast lesion.

Vacuum-assisted percutaneous excision

The control group will undergo standard open surgical excision of the breast lesion. This will be done in the operating room using preoperative image-guided localization with radioactive seed (I-125) or in the procedure room of the Breast Care Centre if appropriate (i.e. lesion is palpable and localization is not required).

Open surgical excision

Muriel Brackstone, PhD, MD

Sarah Knowles, MSc, MD

This randomized controlled trial compares vacuum-assisted percutaneous excision to open standard surgical excision in women who have high-risk or borderline, non-malignant breast lesions with respect to efficacy, safety, cosmesis and patient satisfaction.

In women diagnosed with high-risk or borderline, non-malignant breast lesions, is vacuum-assisted percutaneous excision (VAPE) comparable to open standard surgical excision with respect to efficacy, safety, cosmesis and patient satisfaction?

With the increase in breast imaging for screening there has been corresponding rise in detection of high-risk/borderline, non-malignant breast lesions that require surgical excision to confirm diagnosis and rule out underlying malignancy. Image-guided vacuum-assisted percutaneous excision (VAPE) could offer an alternative to standard open surgical excision for complete excision of these lesions with a possible improvement in patient satisfaction and cosmetic outcomes and decreased complications.

In this single-centre, non-inferiority designed prospective randomized, open label controlled trial, women over 18 years who are found to have a borderline or high-risk, non-malignant breast lesions on core needle biopsy will be considered eligible. Exclusion criteria will be women with a greater than 25% lifetime risk of breast cancer, patients whose pathology and imaging are discordant, and those with extensive calcifications extending over 2cm, a mass larger than 2 cm, or lesions with high-risk features. Informed consent will be obtained and patients will be randomized to standard surgical excision or VAPE. They will then be followed with imaging as appropriate.

The primary outcome measure is the incidence of complete removal of the lesion. The secondary outcome measures are patient satisfaction, cosmetic outcomes and complications such as bleeding and infection.

This trial is the first randomized controlled trial to investigate the role of VAPE compared to standard surgical excision as a means of completely excising borderline or high-risk breast, non-malignant breast lesions. The investigators hypothesize that VAPE will show comparable efficacy and may even have improved safety, cosmesis and patient satisfaction.

Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions

Efficacy, Safety, Cosmesis and Patient Satisfaction With Vacuum-Assisted Percutaneous Excision (VAPE) Compared With Standard Surgical Excision (X) of Non-malignant, Borderline or High-risk Breast Lesions: A Randomized Controlled Trial

As defined by the Center for Disease Control and Prevention (CDC) criteria (Pearson) as infection occurring within the first 30 post-operative days with at least one of the following: (a) purulent drainage from the incision or biopsy site, (b) organisms isolated from an aseptically obtained culture of fluid or tissue, (c) incision is deliberately opened by a surgeon AND patient has at least one of the following signs or symptoms: pain or tenderness, localized swelling, erythema, or heat, or (d) diagnosis of SSI by the surgeon

Any bleeding or hematoma that requires an intervention (such as re-operation to evacuate the hematoma or control the bleeding or aspiration of the hematoma)

No evidence of residual lesion at the time of excision or on follow up imaging exams and no need for further surgical re-excision for residual lesion.

Patient satisfaction as assessed by the BREAST-Q questionnaire for breast conserving therapy, Version 2.0, a validated patient-reported outcome measure that quantifies health-related quality of life and patient satisfaction. It will be completed preoperatively, and at 1, 6, and 12 months postoperatively.

There are three components being assessed:

1. Physical well-being: 10 items scored using a 3-point scale (1=none of the time, 2=some of the time, 3=all of the time).
2. Psychosocial well-being: 10 items scored using a 5-point scale (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time).
3. Satisfaction with breasts: 4 items scored using a 4-point scale (1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied).

Each component has a raw scale summed score (the sum of all the scores for each item) that is converted into a score from 0 (worst) to 100 (best) for analysis.

Cosmesis as assessed by the Modified Harvard-Harris Cosmetic Scale, a validated four-point scale that describes the overall aesthetic appearance of the breasts (categorical scale = excellent, good, fair or poor). It will be administered to both the patients as a self-assessment and the surgeons before the intervention and at various time points postoperatively (1 month, 6 months, and 12 months).

Lawson Health Research Institute

Associate Professor of Surgery & Oncology

Precancerous Conditions

Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.

Participants will receive a placebo (sugar pill) that is designed to mimic ruxolitinib. The placebo will be supplied as four, 5 mg tablets. Participants assigned to this arm will take four, 5 mg tablets by mouth twice daily for 15 days (+/- 5 days).

Ruxolitinib

Placebo (for Ruxolitinib)

Kristen Otte

Shelley Hill

Catherine Parker, MD

Versie Barnes

Carla Fisher, MD

Anton Lulaj

Sheldon Feldman, MD

Crissey Tait

Kristalyn Gallagher, DO

Clinical Trials Information Program

Ingrid Meszoely, MD

Claudette Foreman

Julie Nangia, M.D.

Mothaffar Rimawi, M.D.

Bora Lim, M.D.

C. Kent Osborne, M.D.

Diane Weber, RN

Parijatham Thomas, MD

This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

Ruxolitinib for Premalignant Breast Disease

TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions

The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo.

To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo

Incyte Corporation

Translational Breast Cancer Research Consortium

Julie Nangia

Assistant Professor

Fatigue

Alcohol Deterrents

Narcotic Antagonists

Anti-Infective Agents

Central Nervous System Depressants

Analgesics

Naltrexone

Ethanol

Narcotics

The treatment schedule includes a daily dose of naltrexone for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.

The treatment schedule includes a daily dose of equivalent placebo for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.

Sugar Pill

Fremonta Meyer, MD

Naltrexone is a drug which blocks some effects of chemicals called beta-endorphins that are made in the body. Beta-endorphins can be made in response to stress, injury, and also pleasurable activities. In previous studies, it has been shown that levels of beta-endorphins in the blood go up during radiation therapy, and that this increase is linked to fatigue. This suggests that naltrexone may help to reduce fatigue in people who are getting radiation therapy In this research study, the investigators are looking to see whether naltrexone works better than a placebo in reducing fatigue during radiation therapy.

This trial has two phases (a monitoring and an intervention phase).

Monitoring Phase: Prior to starting radiotherapy for non-metastatic breast cancer, participants will be approached and consented for the monitoring phase of the study, which involves longitudinal monitoring of fatigue in order to establish whether a patient develops fatigue after starting radiation. The level of pre-radiotherapy fatigue will be obtained during the final two weeks before radiotherapy is started. All participants will undergo weekly monitoring of fatigue via a brief self-report questionnaire. The monitoring period will continue up until one month after the conclusion of radiotherapy. Those whose fatigue symptoms increase above the pre-specified threshold at any point during the monitoring period will be approached about enrollment into the intervention phase of the study.

Intervention Phase: This is a randomized, double-blind, parallel-arm 5-week clinical trial which will be used to determine the effect of naltrexone on fatigue emerging during radiation therapy for non-metastatic breast cancer.

Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer

Naltrexone Randomized Controlled Trial for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer

Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al. Cancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue). According to ICD10 criteria, a score \<= 34 indicates significant cancer related fatigue. A change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Principal Investigator

Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.

daily dose placebo for 5 week treatment period

Placebo: Sugar Pill

Total

Age, Continuous

Sex: Female, Male

White

Race/Ethnicity, Customized

United States

Region of Enrollment

The treatment schedule includes a daily dose of naltrexone for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.

Naltrexone

The treatment schedule includes a daily dose of equivalent placebo for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.

Sugar Pill

Change in FACIT-fatigue Subscale Score From Randomization to End of Study

Overall Study

Participants will self-administer FHIR-enhanced RealRisks with access to risk communication games, family history pedigree and modules on chemoprevention and genetics testing, if relevant to them based on their risk and family history. The investigators are interested in gaining short-term feedback on patient activation and other patient reported outcomes, which will be assessed before and within 2 weeks after using RealRisks.

RealRisks is a web-based patient-centered decision aid (DA) designed to improve: 1) accuracy of breast cancer risk perceptions; 2) chemoprevention knowledge, and 3) informed choice. The DA includes audio and modules about breast cancer risk (including interactive games on risk communication) and chemoprevention. Through RealRisks, the investigators will collect information on breast cancer risk factors to calculate a patient's BCSC breast cancer risk score and also factors that influenced decision-making about chemoprevention through the preference elicitation game. RealRisks generates an action plan for patients summarizing their personalized breast cancer risk profile and preference elicitation for chemoprevention. Of note, the tool is designed for patients with varying levels of health literacy and numeracy and is available in English and Spanish.

RealRisks

Rita Kukafka, DrPH, MA

Katherine Crew, MD, MS

Electronic health records (EHRs) are an increasingly common source for populating risk models, but whether used to populate validated risk assessment models or to de-facto build risk prediction models, EHR data presents several challenges. The purpose of this study is to assess how the integration of patient generated health data (PGHD) and EHR data can generate more accurate risk prediction models, advance personalized cancer prevention, improve digital access to health data in an equitable manner, and advance policy goals for Patient Generated Health Data (PGHD) and EHR interoperability.

While breast cancer (BC) mortality has declined, this decline has begun to plateau, particularly among racial/ethnic minorities. Women identified as high-risk for BC may benefit from chemoprevention, testing for BC susceptibility genes, screening, and other personalized risk reducing strategies; however, barriers exist including the time required to conduct risk assessment of each woman in a population. Electronic health records (EHRs), a common source for populating risk assessment models present challenges, including missing data, and data type more accurate when provided by patients compared to EHRs. The investigators previously extracted EHR data on age, race/ethnicity, family history of BC, benign breast disease, and breast density to calculate BC risk according to the Breast Cancer Surveillance Consortium (BCSC) model among 9,514 women. Comparing self-reported and EHR data, more women with a first-degree family history of BC (14.6% vs. 4.4%) and benign breast biopsies (21.3% vs. 11.3%) were identified with patient reported data, but EHR data identified more women with atypia or lobular carcinoma in situ (1.1% vs. 2.3%). The EHR had missing data on race/ethnicity for 26.8% of women and on first-degree family history of BC for 87.2%. Opportunely, Fast Healthcare Interoperability Resources (FHIR), application programming interfaces (APIs), and new legislation offer an elegant solution for automated BC risk assessment that integrates both patient-generated health data and EHR data to harness the strengths of each approach. In prior work, the investigators developed the RealRisks decision aid using an iterative design process to equitably maximize acceptability, and usability. RealRisks promotes understanding of BC risk and collects patient-entered data to calculate BC risk according to the Gail model, BCSC, and BRCAPRO. When FHIR became available, the investigators updated RealRisks to automatically populate information for BC risk calculation from the EHR, and designed a prototype interface that shows this data to patients with a request to review and modify data before running the risk assessments. The investigators recently conducted a feasibility study to demonstrate that EHR data from FHIR could be incorporated into automated BC risk calculation. To increase the likelihood of developing disseminatable and equitable strategies that integrate EHR and PGHD data for risk assessment and personalized BC risk-reduction, the focus is to refine and test our approach among diverse multiethnic women. The aims are: 1) conduct user evaluations to refine FHIR-enhanced RealRisks; 2) assess the effect of the FHIR-enhanced RealRisks on patient activation, risk perception, and usability in a pilot study of multiethnic high-risk women; and 3) identify multilevel barriers to implementing FHIR-enhanced RealRisks into clinical care. Given the mortality associated with BC, focused efforts are needed to provide accurate risk assessment and shared decision-making about risk-reducing strategies, especially in minority women who are more likely to be diagnosed with advanced stage BC. If successful, the approach tested in this application may provide a roadmap for broadly improving digital access to health data and reducing BC mortality in an equitable manner.

The investigators will conduct a pre-/post- feasibility study of 55 high-risk diverse multiethnic women with follow-up to assess accuracy of breast cancer risk perception (perceived lifetime risk minus actual risk according to the Gail model) and patient activation.

RealRisks is a patient-facing, web-based decision support tool that was developed using multiple design sessions, participatory workshops, and usability studies to arrive at guiding principles that focus on 1) personalized breast cancer risk calculation, 2) interactive games to communicate breast cancer risk, and 3) patient preferences elicitation to elicit values supporting breast cancer options. The FHIR enhanced-RealRisks functionality that this research focuses on will allow RealRisks to utilize a patient's electronic health record data to support accurate risk assessment.

FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments

Integrating EHR and Patient-generated Health Data for Breast Cancer Risk Assessment and Decision Support in a Diverse Multiethnic Population

Measured via the Perceived Health Web Site Usability Questionnaire (PHWSUQ), three separate sections to evaluate patient satisfaction (e.g., "It is easy to find specific information"), ease of use (e.g., "It was easy to understand how to get to EHR data"), and usefulness (e.g., "Using the FHIR-enhanced RealRisks will help me improve my understanding about my BC risk; what I can do to reduce my risk"). The PHWSUQ consists of 12 items on a 7-point Likert scale ranging from Very Unsatisfied (1) to Very Satisfied (7). Scores range from 12-84, with a higher scores indicating greater overall usability of the tool.

Validated 13-item Patient Activation Measure, which measures patient knowledge, skill, and confidence in self-management of health. Scores range from 0 to 100; higher scores indicate greater activation.

Difference between perceived numeric risk estimate and actual lifetime breast cancer risk score, according to the Gail or BCSC risk models, categorized as accurate if the difference between subjective and objective risk estimates are 10% in either direction, underestimate if \>10% below objective risk, and overestimate if \>10% above objective risk.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion	NCT06033092	BRCA Mutation PALB2 Gene Muta... Ductal Carcinom... Lobular Carcino... ATM Gene Mutati... CHEK2 Gene Muta... CDH1 Gene Mutat... RAD51C Gene Mut... RAD51D Gene Mut...	Tamoxifen 10 mg... Intermittent ca... Step counter De...	18 Years - 70 Years	European Institute of Oncology
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion	NCT06033092	BRCA Mutation PALB2 Gene Muta... Ductal Carcinom... Lobular Carcino... ATM Gene Mutati... CHEK2 Gene Muta... CDH1 Gene Mutat... RAD51C Gene Mut... RAD51D Gene Mut...	Tamoxifen 10 mg... Intermittent ca... Step counter De...	18 Years - 70 Years	European Institute of Oncology
Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions	NCT03868475	Breast Fibroade... Atypical Ductal... Atypical Lobula... Lobular Carcino... Flat Epithelial... Phyllodes; Fibr... Phyllodes Breas... Radial Scar Breast Papillom... Complex Scleros...	Vacuum-assisted... Open surgical e...	18 Years -	Lawson Health Research Institute
Ruxolitinib for Premalignant Breast Disease	NCT02928978	Ductal Carcinom... Atypical Lobula... Atypical Ductal... Lobular Carcino...	Ruxolitinib Placebo (for Ru...	18 Years -	Baylor Breast Care Center
Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer	NCT02137252	Invasive Breast... Ductal Carcinom... Lobular Carcino... Lobular Carcino... Fatigue Related...	Naltrexone Sugar Pill	18 Years -	Dana-Farber Cancer Institute
FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments	NCT05810025	Breast Cancer	RealRisks	35 Years - 74 Years	Columbia University

Spots Global Cancer Trial Database for lobular carcinoma in situ