Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Tamoxifen

Hormones

Liver Extracts

Anastrozole

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Aromatase Inhibitors

Enzyme Inhibitors

Vivian Gu

Fengping Liang

Prof. Wang Shenming

The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

Liver Safety Under Upfront Arimidex vs Tamoxifen

A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer

The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

AstraZeneca

Anastrozole(ARIMIDEX): 1 mg once daily oral dose

Arimidex Group

TAM Group

Total

Age Continuous

Sex: Female, Male

James J. Armbrust

48 weeks

96 weeks

144 weeks

Incidence of Fatty Liver Disease

Incidence of Abnormal Liver Function

Time to Treatment Failure

Overall Study

Immune System Diseases

Hypersensitivity

Mitogens

Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).

ZN-c5

Abemaciclib (VERZENIO®) is an approved drug.

Abemaciclib

Carrie Brownstein, MD

This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.

All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.

A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer

A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.

Zeno Alpha Inc.

Palbociclib

Protein Kinase Inhibitors

Patients who initiated first or subsequent lines of treatment with palbociclib

palbociclib

Pfizer CT.gov Call Center

The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy.

This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body.

Patients are followed for around 3.5 years.

A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.

DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment is palbociclib combination treatment.

Duration in months between the start and stop of therapy was reported. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.

Number of participants categorized according to number of cycles of treatment included less than or equal to (\<=) 6, greater than (\>) 6 to 11, \>11 to 20 and \>20 cycles were reported. Index treatment is palbociclib combination treatment.

Number of participants were categorized according to initial palbociclib dose. Index treatment is palbociclib combination treatment.

Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment is palbociclib combination treatment.

Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment included chemotherapy, everolimus plus exemestane, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.

Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment is palbociclib combination treatment.

Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment is palbociclib combination treatment.

Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment is palbociclib combination treatment.

Number of participants who died following index treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.

Number of participants who died following index treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.

Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.

Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.

Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.

Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.

Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.

TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.

Pfizer

Due to non-interventional nature of the study, data for SAEs and non-SAEs were not collected.

Participants with HR+/HER2- metastatic breast cancer, who had initiated palbociclib combination treatment in real world clinical practice as per the national basket of health services, were observed during this population based retrospective database study.

Age, Continuous

<=65 Years

>65 Years

Age, Customized

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Body Mass Index (BMI)

Number of participants were classified according to BMI as underweight (BMI less than \[\<\]18.50 kilogram per meter square \[kg/m\^2\]), normal (BMI 18.50-24.99 kg/m\^2), overweight (BMI 25.00-29.99 kg/m\^2), obese (BMI greater than or equal to \[\>=\] 30 kg/m\^2) and missing.

Number of Participants Categorized According to BMI

Number of participants were classified according to smoking history as current or former and never or unknown.

Number of Participants According to Smoking History

Number of participants according to region of residence included north, south and central region were reported.

Number of Participants According to Region of Residence

Number of participants were classified according to socioeconomic status as low, medium and high.

Number of Participants According to Socioeconomic Status

Diabetes mellitus

Cardiovascular disease

Ischemic heart disease

Hypertension

Chronic obstructive pulmonary disease (COPD)

Osteoporosis

Menopause

Participants with their co-morbidities diagnosed 1 year prior to palbociclib initiation were reported. One participant could have more than 1 co-morbidity so 1 participant could be included in more than 1 row reported below.

Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation

Number of participants with depression as defined by international classification of diseases, ninth revision (ICD-9) codes were reported below.

Number of Participants With Chronic Disease - Depression

Deyo-Charlson co-morbidity index was used to determine presence/absence of disease using international classification of diseases, ninth revision, clinical modification (ICD-9-CM) codes and MHS registries. It was calculated based on the presence of 19 comorbidities which have been selected and weighted on the basis of the strength of their association with mortality. Total score ranged from 0 to 9. A score of zero indicated that no comorbidities were found. The higher the score, the more likely the cumulative severity of a participant's comorbidities.

Number of Participants According to Deyo-Charlson Comorbidity Index Categories

Number of participants who used other medications i.e. other than palbociclib (at least 2 purchases) within 3 months prior to index date (palbociclib initiation) were included.

Number of Participants who Used Other Medications Prior to Palbociclib Initiation

Number of participants who visited community/hospital for genetic counselling for germline breast cancer gene mutation (gBRCAm) before index date were reported. Index date is date for initiation of palbociclib.

Number of Participants who Visited Community/Hospital for Genetic Counselling

Number of participants whose gBRCAm test was performed were reported.

Number of Participants With Germline Breast Cancer Gene Mutation (gBRCAm) Test Performed

Number of participants according to histology of breast cancer as invasive ductal, invasive lobular, lobular and ductal and other/missing/unknown were reported.

Number of Participants According to Histology of Breast Cancer

Visceral

Lymph

Bone

Brain

Number of participants according to location of metastases included visceral (lung, liver, abdomen or skin), lymph, bone and brain were reported. One participant could have more than 1 location so 1 participant could be included in more than 1 row.

Number of Participants According to Location of Metastases

ECOG performance status was used to assess the physical health of participants and ranged from 0 to 5. where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled. cannot carry on any selfcare and Grade 5: dead. Number of participants according to ECOG status were reported.

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of participants according to hormone receptor sensitivity status included estrogen receptor positive (ER+)/progesterone receptor positive (PR+), ER+, PR+ and missing were reported.

Number of Participants Categorized According to Hormone Receptor Sensitivity

Analysis population included all participants whose data were included and observed in the study.

Pfizer ClinicalTrials.gov Call Center

Number of Participants Categorized According to Type of Index Combination Treatment Regimen

Palbociclib + AI

Palbociclib + Fulvestrant

Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Duration of Index Treatment Per Type of Combination Treatment

Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment

Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment

Palbociclib+ Fulvestrant

Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment

Palbociclib + AI: Chemotherapy

Palbociclib + AI: Everolimus+Exemestan

Palbociclib + AI: Fulvestrant

Palbociclib + AI: Other

Palbociclib + Fulvestrant: Chemotherapy

Palbociclib + Fulvestrant: Everolimus+Exemestan

Palbociclib + Fulvestrant: Other

Analysis population included all participants whose data were included and observed in the study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment

Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment

Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment

Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment

Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment

Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment

Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment

Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment

Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment

Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment

Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment

Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment

Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 as well as expansion cohorts and a Phase 2 cohort.

Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 in combination with palbociclib as well as a Phase 2 cohort.

Palbociclib (IBRANCE®) is an approved drug

Zeno Alpha, Inc.

This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).

Dose escalation cohorts are planned in monotherapy and combination as well as monotherapy dose expansion, and monotherapy and combination Phase 2.

A Study of ZN-c5 in Subjects With Breast Cancer

A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liver Safety Under Upfront Arimidex vs Tamoxifen	NCT00537771	Breast Cancer	Anastrozole Tamoxifen	-	AstraZeneca
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer	NCT04514159	Breast Cancer	ZN-c5 Abemaciclib	18 Years -	Zeno Alpha Inc.
A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.	NCT04671615	Metastatic Brea...	palbociclib	18 Years - 99 Years	Pfizer
A Study of ZN-c5 in Subjects With Breast Cancer	NCT03560531	Breast Cancer	ZN-c5 Palbociclib	18 Years -	Zeno Alpha Inc.
Neoadjuvant Treatment of Breast Cancer	NCT00254592	Breast Cancer	Doxorubicin Cyclophosphamid... Carboplatin Nab-paclitaxel GM-CSF Trastuzumab Bevacizumab	18 Years -	University of California, Irvine
Neoadjuvant Treatment of Breast Cancer	NCT00254592	Breast Cancer	Doxorubicin Cyclophosphamid... Carboplatin Nab-paclitaxel GM-CSF Trastuzumab Bevacizumab	18 Years -	University of California, Irvine
A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer	NCT01216176	Breast Cancer	Anastrozole AZD0530 (saraca... Placebo	18 Years -	University of Miami
A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.	NCT04671615	Metastatic Brea...	palbociclib	18 Years - 99 Years	Pfizer
Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)	NCT00968409	Breast Cancer	PET Laboratory Test... Safety Testing F18-FFNP	18 Years -	Washington University School of Medicine
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast	NCT04666805	Breast Cancer	Tamoxifen Toremifene Anastrozole Letrozole Exemestane	18 Years - 85 Years	First Hospital of China Medical University

Spots Global Cancer Trial Database for hormone receptor