Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Analgesics

All Drugs and Chemicals

Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.

Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment

Patients have 3-monthly geriatric follow-up with biological tests, anti-aromatase agents blood dosing and a clinical assessment (M3 to M9, M15 to M22 and M27 to M33). Musculoskeletal adverse events and quality of life level will be reported and analgesic treatment adapted. Patients will be proposed weekly Taï-Chi exercises to improve joint flexibility, muscular tonus and balance and reduce fall risk.

A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36).

Arm A: adapted physical activity + enhanced geriatric follow-up

No intervention

Claire Falandry, MD-PhD

PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.

Patients in the intervention group will be proposed:

* A regular geriatric follow up including an attentive screening of joint symptoms and functionality,
* An adapted treatment of join pain,
* Weekly sessions of adapted physical activity (Taï Chi),
* And a systematic correction of vitamin D deficits.

PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program

PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.

Compliance rate is defined as the rate of blood samplings of anti-hormone metabolites in the therapeutic range, within the 7 blood samplings distributed in the 3 years of follow-up

Musculoskeletal adverse events will be graded using NCI CTC version 4.0

Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire

Using Mini Nutritional Assessment, weight, weight loss, albuminemia

issued from the exhaustive list of documented concomitant medications

Hospices Civils de Lyon

Herbal and Botanical

Orange

Breast cancer patients, currently taking adjuvant endocrine therapy will be equipped with a GlowCap device for a period of 30 days. The GlowCap will become part of their medication taking routine.

Participants will be provided with a device called the GlowCap for a period of 30 days. The device has visual and auditory cues to help patients remember to take their medication at the same time each day. The GlowCap will be programmed to glow when it is time for each patient to take her medication. The GlowCap will initially glow bright orange for the first hour from the time the patient is scheduled to take the medication. During the second hour, the GlowCap system will play music in addition to continuing to glow. If after 2 hours the patient still has not opened the medication bottle, she will receive a phone call reminding her to take her medication.

GlowCap device

Tiffany Traina, MD

The purpose of this study is to test the ease of using a new device, called the GlowCap that reminds the patient to take their breast cancer hormone pill. The study will collect information about the experience with this device and what the patient thinks of its role in the daily pill taking routine.

GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy

Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy

\>60 years of age with early stage breast cancer.

with respect to medication adherence in patients \>60 years with early stage breast cancer taking adjuvant endocrine therapy.

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Carcinoma

Neoplasm Micrometastasis

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

Bone Density Conservation Agents

Reproductive Control Agents

Trastuzumab

Pertuzumab

Tamoxifen

Hormones

Exemestane

Letrozole

Leuprolide

Anastrozole

Antineoplastic Agents, Immunological

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Study treatment will be administered in 21-day (3- week, +/- 3 days) cycles for one year (18 cycles).

* Trastuzumab + Pertuzumab SC fixed dose combination
* Hormonal therapy- oral, daily per cycle (may add LHRH agonist per investigator discretion)

Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose

Pertuzumab+TRASTUZUMAB

ADJUVANT ENDOCRINE THERAPY

Adrienne Waks, MD

K.M. Steve Lo, MD

K. M. Steve Lo, MD

Ashley Trumball

Jane Meisel, MD

Tarah Ballinger, MD

Tarah J Ballinger, MD

Laurie Lewis

Sarah J Sinclair, DO

Nadine Tung, MD

Natalie Sinclair, MD

Meredith Faggen, M.D.

Meredith Faggen, MD

Stefani Freeman, RN

Jeanna Walsh, MD

Breast Cancer Center

Sylvia Adams, MD

Julia Rauch, MD

Crissey Tait

Lisa Carey, MD

Julia Raugh, MD

Nicole Williams, MD

Denise A. Yardley, MD

Denise Yardley, MD

Vandana Abramson, MD

Pamela Lewis

Vicente Valero, MD

Adrienne C Waks, MD

This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer.

The study drugs involved in this study are:

* A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO)
* Hormonal (endocrine) Treatment

The research study procedures include screening for eligibility and study treatment including laboratory evaluations, physical exams, questionnaires, and follow up visits.

* Participants will receive HER2-directed treatment for 1 year and hormonal therapy for approximately 5 years.
* It is expected that about 375 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. The U.S. Food and Drug Administration (FDA) has approved trastuzumab, pertuzumab, and trastuzumab + pertuzumab subcutaneous fixed dose combination (PHESGO) as treatment for HER2 positive breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer.

.

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

assessed by Voils questionnaire. Responses to survey items will be summarized using means or proportions depending on the nature of the questions.

The FACT-B includes the FACT-G, a 27-item generic cancer questionnaire and a 10- item breast cancer specific module. Responses to survey items will be summarized by means or proportions depending on the nature of the items

The Activity Level Scale Domain from the RSCL is an 8-item scale designed to measure whether the respondent can perform a series of activities at the present time. Items are summed to produce an overall score, with higher scores representing better functioning.

Responses to survey items will be summarized by means or proportions

The WPAI was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health (WPAI:GH) or a specific health problem (WPAI:SHP). The 6 questions in the WPAI questionnaire were generated from three main sources Responses to survey items will be summarized by means or proportions depending on the nature of the items

There is increasing recognition of the profound importance of the financial strain on patients created by cancer diagnosis and therapies. The COST (Comprehensive Score for financial Toxicity) measure has been developed and validated as a mechanism to assess financial stress related to cancer diagnosis and treatment Responses to survey items will be summarized by means or proportions

The HPASQ-SC (Appendix C) is a tool to measure patient-reported outcomes regarding patient acceptance of subcutaneous therapy. It was developed and underwent validity testing in a cohort of patients receiving subcutaneous rituximab for lymphoma. The HPASQ-SC contains questions related to two main concepts (treatment satisfaction and impact of treatment administration) and eight sub-concepts: overall preference/satisfaction; convenience; confidence; bothersome-ness; physical impact; psychological impact; impact on activities of daily life; and impact on the interaction with healthcare providers.21

Responses to survey items will be summarized by means or proportions

Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals.

from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause

RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer

defined as the time period between randomization and death due to breast cancer.

OS will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal).

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting

Mean difference will be estimated between HP FDC SC and IV admin of HP in sub-study

Genentech, Inc.

Dana-Farber Cancer Institute

Sponsor Investigator

The intervention is an 8-week combined aerobic and resistance program, with virtual, group-based, supervised exercise sessions twice per week (60 min). The intervention also includes optional education on healthy eating.

Usual lifestyle control for 8 weeks and then invited to participate in the exercise intervention.

This study is a partial cross over study. The intervention is 8 weeks in duration. Participants will be randomized to immediate exercise or delayed exercise, and the delayed exercise group will cross over to the intervention after 8 weeks.

Immediate Intervention Group

Delayed Intervention Group

Kelly Mackenzie, MSc

Aaliya Merali-Dewji, MSc

Kristin L Campbell, PhD

This project will assess the efficacy of an 8-week virtual exercise program on physical function offered to those with a breast cancer diagnosis currently receiving endocrine therapy. The intervention includes twice-weekly virtual group exercise classes. Participants also complete one to three independent home exercise sessions per week throughout the intervention. Testing will occur virtually at baseline, 8-weeks (at end of program) and follow-up evaluations will be performed at 16-weeks and 12- months after baseline testing. Questionnaires will be administered through REDCap. Exercise sessions and testing will be administered virtually via Zoom.

Purpose: The purpose of this study is to test the effect of a virtually delivered supervised exercise program specific to breast cancer survivors on endocrine therapy versus delayed exercise in a partial cross over trial.

Justification: Endocrine therapy is commonly prescribed to breast cancer survivors for 5-10 years and often leads to side effects such as arthralgia, weight gain and bone density loss. Exercise has been shown to be an effective management strategy of these side effects and may improve quality of life and physical functioning. Many barriers exist surrounding the implementation of exercise programs for breast cancer survivors, despite the efficacious outcomes exercise programs have been shown to provide.

Due to COVID-19, virtual delivery options are needed to continue to provide exercise support to cancer patients. In September 2020, members of the investigator team successfully completed a pilot of the virtual intervention (n=30). In British Columbia, the investigators are well positioned to trial the implementation of an exercise program from a virtual setting, with programming specific to women receiving endocrine therapy. The knowledge gained from this study, if shown to be effective, will assist future program delivery and implementation across British Columbia for breast cancer survivors.

Aims and Objectives:

Primary Aim: To evaluate the efficacy of the exercise intervention group versus delayed exercise group to improve physical function, as measured by 30 second sit to stand test, from baseline to end of program (8-weeks).

Secondary Aim: To evaluate the preliminary efficacy of the intervention to improve endocrine therapy medication adherence (voils DOSE-non adherence measure) and endocrine symptom scores (FACT-ES) from baseline to end of program (8-weeks).

Tertiary Aim: To evaluate the preliminary efficacy of the intervention at improving exercise levels (modified Godin), health related quality of life (RAND), balance (tandem balance test) and self-reported anthropometric measures (weight, height, waist and hip circumference) from baseline to end of program (8-weeks).

Exploratory Aims: 1) To obtain additional data on efficacy outcomes (all outcomes listed above) with with-in group analysis of delayed exercise intervention group (0-8 weeks vs. 9-16 weeks) to further refine efficacy estimates to inform future implementation trials; and 2) to examine suitability of efficacy outcomes at 16-weeks (immediate intervention group only) and in both intervention arms, namely end of intervention 8- or 16-weeks, as appropriate to 12-months after baseline testing.

It is hypothesized that the intervention will improve physical function at 8 weeks. Additionally, it is hypothesized that the intervention will improve medication adherence, reduce self-reported endocrine symptoms, health-related quality of life, increase exercise levels, balance and anthropometrics at 8 weeks. The exploratory aims will provide information on maintenance effect in the short term (16 weeks) and longer term (12 months from enrollment).

Research Design: This study is a partial cross over study. The intervention is 8 weeks in duration. Participants will be randomized to immediate exercise or delayed exercise, and the delayed exercise group will cross over to the intervention after 8 weeks. This design was selected to optimize recruitment (all participants receive the intervention) while allowing appropriate comparison of intervention versus control, and to gain additional insights into efficacy of the intervention in order to better design future implementation studies. No washout period between crossover arms needed. Participants will undergo a virtual baseline assessment, 16 supervised virtual group-based exercise sessions delivered twice weekly, a final assessment at completion of the 8-week exercise program, as well as follow-up assessment at 16-weeks and 12-months after baseline testing. All sessions will take place virtually via a secure Zoom platform.

Statistical Analysis: Between group comparisons of those randomized to immediate intervention versus delayed intervention for changes in primary, secondary and tertiary outcomes from baseline to 8-weeks will be assessed using two-sample t-tests for normally distributed quantitative outcomes (primary, secondary, and tertiary). For highly skewed quantitative outcomes, the comparisons will be done using Mann-Whitney tests. For categorical outcomes, comparisons will use chi-square tests of independence (and Fisher Exact tests for binary outcomes).

For the delayed intervention group, within-group comparisons to assess changes from baseline (i.e., no intervention) to 16 weeks (i.e., after 8 weeks of delay plus 8 weeks of active intervention) will be done with paired t-tests for normally distributed outcomes, and Wilcoxon signed-rank tests for skewed quantitative outcomes.

A more formal repeated measures analysis of variance will be done to examine the change across multiple time points, which are baseline, 8 weeks, 16 weeks and 12-months. All tests will be two sided with a nominal level of significance of 5%.

An interim analysis will be undertaken once fifty percent of the planned sample size has been recruited and randomized. The aim of this analysis is to: 1) re-examine the target sample size using study data to compute effect size, and update if necessary; and 2) assess whether the trial should be stopped either due to tremendous efficacy or likely futility. This will be completed by the project statistician, and all other study team members will remain blinded, so that the randomization will not be jeopardized.

Breast Cancer Endocrine Therapy FITness (BE-FIT) Trial.

Measured by Voils DOSE-non adherence measure; where higher scores indicate greater levels of nonadherence.

Measured by RAND 36-Item Short Form Health Survey

Modified Godin Leisure Time Physical Activity questionnaire

Aggregated measure of height and weight, reported in kg/m\^2

British Columbia Cancer Agency

University of British Columbia

Professor

Goserelin

Patients who were anticipated to receive adjuvant OFS+AI endocrine therapy according to MDT discussion results were randomized to this arm,they will receive OFS+Anastrozole.

Patients who were anticipated to receive adjuvant OFS+AI endocrine therapy according to MDT discussion results were randomized to this arm,they will receive OFS+Exemestane.

Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.

Patients will take anastrozole 1mg qd.

OFS + Anastrozole

Patients will take exemestane 25mg qd. Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.

OFS + Exemestane

Kunwei Shen, Professor

To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.

Safety of OFS Combined With AI Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients

Safety of Ovarian Function Suppression(OFS)Combined With Different Aromatase Inhibitors(AIs) Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients：A Randomized, Controlled, Prospective, Observational Study

Bone and joint pains are measured by National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) classification v4.0 every 3 months.

Shanghai Jiao Tong University School of Medicine

Toremifene

Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would switch to receive Zoladex 3.6mg depot subcutaneously every month and Aromidex 1mg/d po for another 3-2 years

Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would receive TAM 20mg/d treated for 3-2 years.

Zoladex+AI

Zhi-min Shao, MD

Ya-jie Ji, MD

The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone receptor positive, lymph node positive or tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories (table 3-1), and only those with ER or PR expression undetectable were considered as HR negative. The pathological evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or directly through ALND when axillary nodes appeared to be positive in clinical examination. Based on the operating standard of local medical institution, identifying the numbers of lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station nodes accurately.

Adjuvant AI Combined With Zoladex

A Randomized ,Open Label Study Comparing the Efficacy of Zoladex® Combined With Arimidex® for 3-2 Years After Selective Estrogen Receptor Modulators (SERMs) as an Adjuvant Therapy for 2-3 Years Versus Continuing Tamoxifen up to 5 Years for Premenopausal Early Breast Cancer Patients With Hormone Receptor Positive, Lymph Node Positive or Tumor≥ 4cm.

Disease free survival (DFS): DFS related events ware defined as local recurrence, distant metastasis, secondary primary cancer or death, whichever occurred first.during follow up

Bilateral secondary primary breast cancer morbidity

Osteoporosis related events ( BMD and bone fracture incidence)

Other adverse events (Gynecological events, blood lipids, thrombosis, cardiovascular diseases, and etc.)

Fudan University

Fudan University Shanghai Cancer Center

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Anti-Obesity Agents

Vasoconstrictor Agents

Respiratory System Agents

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Early Breast Cancer patients receiving adjuvant endocrine therapy

Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.

Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao

Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.

Xinglinggubao: 0.5g bid po

Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine)

Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.

Zhongyaofufang: qow po

Letrozole endocrine therapy for 2.5mg qd po.

Traditional Chinese Medicine for patients with Osteoporosis

Zhongyaofufang

Xianlinggubao

Kunwei Shen, MD

To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy

Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy

The change of bone mineral density of the L2-L4 region of the spine and hip between pre- and post-endocrine therapy for one year

the rate of bone fracture in patient receiving endocrine therapy

The change of bone metabolism assessed by the scale of serum bone alkaline phosphatase, serum C-telopeptide and urineN-telopeptide between pre- and post-endocrine therapy for one year

women candidate to receive ET and interviewed before starting treatment

women interviewed within 1 years from beginning of ET

women interviewed after more than 4 years but no more than 6 years of ET

Completion of questionnaires at the time of study entry

Completion of questionnaires

Emilia Montagna, MD

Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.

They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.

Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.

Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.

The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.

In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients.

Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients.

The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment.

Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.

It is important therefore to consider also the influence of these factors on the patients' treatment preferences.

For this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires.

Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.

Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios

Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program	NCT02216162	Breast Cancer	Arm A: adapted ... No intervention	70 Years -	Hospices Civils de Lyon
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program	NCT02216162	Breast Cancer	Arm A: adapted ... No intervention	70 Years -	Hospices Civils de Lyon
GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy	NCT01239251	Breast Cancer	GlowCap device	60 Years -	Memorial Sloan Kettering Cancer Center
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer	NCT04569747	HER2-positive B... Invasive Carcin... Breast Cancer Node Negative B... Micrometastasis... Hormone Recepto...	Pertuzumab+TRAS... ADJUVANT ENDOCR...	18 Years -	Dana-Farber Cancer Institute
Breast Cancer Endocrine Therapy FITness (BE-FIT) Trial.	NCT04824339	Breast Neoplasm...	Immediate Inter... Delayed Interve...	19 Years - 75 Years	University of British Columbia
Safety of OFS Combined With AI Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients	NCT02440230	Breast Cancer	OFS + Anastrozo... OFS + Exemestan...	18 Years -	Shanghai Jiao Tong University School of Medicine
Adjuvant AI Combined With Zoladex	NCT01352091	Breast Cancer	Zoladex+AI TAM	18 Years -	Fudan University
Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy	NCT02455154	Breast Cancer Osteoporosis	Letrozole Zhongyaofufang Xianlinggubao	18 Years -	Shanghai Jiao Tong University School of Medicine
Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer	NCT03939156	Breast Cancer Endocrine Breas...	Completion of q...	18 Years -	European Institute of Oncology
Safety of OFS Combined With AI Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients	NCT02440230	Breast Cancer	OFS + Anastrozo... OFS + Exemestan...	18 Years -	Shanghai Jiao Tong University School of Medicine

Spots Global Cancer Trial Database for adjuvant endocrine therapy