Heart and Blood Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Nervous System Diseases

Rare Diseases

Diabetic Foot

Ulcer

Diabetic Angiopathies

Vascular Diseases

Foot Ulcer

Leg Ulcer

Skin Ulcer

Skin Diseases

Diabetes Mellitus

Diabetes Complications

Endocrine System Diseases

Diabetic Neuropathies

Chronic Graft Versus Host Disease

Anticoagulants

All Drugs and Chemicals

Becaplermin

Angiogenesis Inducing Agents

Becaplermin gel 100 µg/g versus placebo gel (up to 12 applications).

Sterile becaplermin gel vs. sterile placebo gel treatment 1

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials \[neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005\].

This single-visit, retrospective study was designed to evaluate the long-term safety of becaplermin gel 100 mcg/g versus placebo gel. Patients previously enrolled in protocol PDGF-DBFT-003 or PDGF-DBFT-005 were evaluated during a single-study visit in which retrospective safety data were collected. Recurrence data on the Target Ulcer were also obtained. The maximum number of patients in this study was the sum of patients enrolled in the 2 previous trials. The investigators made every effort to contact all patients enrolled in the previous double-blind trials in order to get follow-up information on as many patients as possible. If the patient was deceased, the cause of death, if known, was collected by the investigator (where permitted by the local authorities). After evaluation of the entrance criteria, demographic data, significant new intercurrent illnesses, a current medication profile, therapies received for the treatment of any diabetic neuropathic foot ulcer and surgeries in the last 12 or more months were collected and recorded. A questionnaire was used by the investigational staff to elicit patient information. At the visit, a complete physical examination was done (special attention was given to assess the presence of any malignancies), the feet were carefully examined and the footwear was assessed. The site of the Target Ulcer treated in the previous double-blind trial was assessed by an independent dermatologist.and photographs of the heel, back, inside and outside surfaces of the foot, as well as a distance photograph of the foot, were taken. Parameters such as major changes in the general health, (i.e., hospitalizations, major illnesses, and past surgeries), and past as well as present histories of any malignant diseases were carefully assessed. Of primary interest were the examination of previously treated ulcer site(s) and the Target Ulcer limb in general, for recurrences and/or new ulcerations; their treatments and outcomes; and any other relevant changes to the previously treated ulcer and the surrounding skin. Observational study - No study drug administered

Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers

A Multicenter Clinical Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Clinical Leader, Internal Medicine, EP

Neoplasms

Breast Neoplasms

Breast Diseases

Antineoplastic Agents

Hormones

Fulvestrant

Mitogens

Palbociclib

Aromatase Inhibitors

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Protein Kinase Inhibitors

Enzyme Inhibitors

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor.

Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.

Aligned with Locally Approved Indication

Adult metastatic breast cancer patients who initiated Palbociclib + fulvestrant. Data will be retrospectively abstracted over an observational look-back period from 01st January 2015 to 30th September 2019.

Aligned with Locally Approved Indication

Palbociclib plus an aromatase inhibitor therapy

Palbociclib plus an aromatase inhibitor

Palbociclib plus fulvestrant

Pfizer CT.gov Call Center

Meteb Al-Foheidi

retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2- metastatic/locally advanced breast cancer (BC)

Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region

Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region Like Saudi Arabia, UAE and Other GCC Countries: A Retrospective Study (Treasure Study)

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.

Biomarker status - (estrogen receptor \[ER\], progesterone receptor \[PR\], HER-2 neu, Ki67, Germline BRCA \[gBRCA\] testing).

Description of diagnosis - staging, node status, menopause status, diagnosis for which palbociclib combination was prescribed, sites of metastases, de novo vs. recurrent disease.

Adjuvant therapies received for the treatment of early or locally advanced breast cancer (Stages 0-IIIa) (if available)

Treatments and supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis. Duration of treatments. Reasons for regimen changes. Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible reasons for change in treatment. Line of treatment.

Starting dose, duration of treatment, changes in dose, interruptions, cycle delays and discontinuations. Where possible, reasons for change in treatment. Line of treatment.

Supportive therapies received since metastatic/locally advanced HR+/HER2- diagnosis while receiving palbociclib combination treatments. Duration of treatments.

Proportion of progression free survival/time to progression (at intervals per standard of care) (eg. 12, 18 months).

Proportion of objective response rate (at intervals per standard of care).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers	NCT00740922	Platelet-Derive... Diabetic Foot Neoplasms	Sterile becaple...	-	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers	NCT00740922	Platelet-Derive... Diabetic Foot Neoplasms	Sterile becaple...	-	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region	NCT04916509	Breast Neoplasm...	Palbociclib plu... Palbociclib plu...	18 Years -	Pfizer

Spots Global Cancer Trial Database for retrospective studies