Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Abiraterone Acetate

Prednisone

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily for 28-day cycles

Abiraterone acetate

Prednisone or prednisolone

Janssen Research & Development, LLC Clinical Trial

The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.

This is an open-label (identity of assigned study drug will be known) early access protocol (EAP). Approximately 60 participants will be enrolled in this study. Participants will receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily. Treatment in 28-day cycles will continue until progression of clinical disease. Study drug will be provided until the company obtains market authorization and reimbursement in the participant countries for this indication.

A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer

Janssen Research & Development, LLC

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Ado-Trastuzumab Emtansine

Trastuzumab

Pertuzumab

Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program

Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program

Belén Ruiz-Antorán, PhD

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine

Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive

The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).

Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record

The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.

The time from start of treatment to the date of the first confirmed response (evaluated for responders only)

* AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration)
* AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease

* An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab)
* Other AEs leading to treatment discontinuation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer	NCT01834209	Prostate Neopla...	Abiraterone ace... Prednisone or p...	18 Years -	Janssen Research & Development, LLC
Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine	NCT03025711	Breast Neoplasm...		18 Years - 100 Years	Puerta de Hierro University Hospital

Spots Global Cancer Trial Database for early access program