Abiraterone Acetate in Molecular Apocrine Breast Cancer
AMA
A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer
3 other identifiers
interventional
34
1 country
36
Brief Summary
The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jul 2013
Typical duration for phase_2 breast-cancer
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
April 29, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2018
CompletedFebruary 23, 2021
February 1, 2021
2 years
April 24, 2013
February 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical benefit rate (CBR)
The 6-months CBR is the measurement of all patients who have a complete response (CR), partial response (PR) or stable disease (SD), according to RECIST criteria v1.1. At six months, patients will be classified as success (Alive at 6 months AND CR/PR/ SD) or failure (dead OR alive with progression).
at 6 months
Secondary Outcomes (5)
Objective response rate (ORR)
at 6 months
Duration of overall response (DoR)
at 6 months
Overall Survival (OS)
median follow-up = 2 years
Progression-free survival (PFS)
median follow-up = 2 years
Overall safety profile
during the on-treatment period (defined as the period from the time of first dose of study medications up to 30 days of the last dose)
Study Arms (1)
Abiraterone Acetate
EXPERIMENTALInterventions
Patients will receive abiraterone acetate at 1,000 mg (four 250 mg tablets daily in the morning after an overnight fast) concurrently with prednisone(1) at 10 mg once daily.
Eligibility Criteria
You may qualify if:
- Women aged ≥18 years;
- Histologically confirmed locally advanced or metastatic breast cancer;
- Triple negative breast cancer:
- Patients could be chemotherapy naïve (provided they are not presenting with life-threatening metastasis) or have received any number of previous lines of chemotherapy (providing their life expectancy is ≥3 months);
- Pre and post menopausal patients are eligible.
- Measurable or non measurable disease according to RECIST v1.1 criteria;
- PS (ECOG) ≤2;
- Normal haematological function: ANC ≥1,500/mm3; platelets count ≥100,000/mm3; haemoglobin \>10 g/dl;
- Normal hepatic function: total bilirubin ≤1.5 upper normal limit (UNL); ASAT and ALAT ≤2.5 UNL (≤5 UNL in the presence of liver metastases);
- Creatinine clearance (MDRD formula) ≥50 mL/min OR creatinine ≤1.5 times ULN;
- Normal kalemia (serum potassium ≥3.5 mM), natremia and magnesemia;
- Patient agreeing to use effective contraception during and for ≥ 6 months after completion of study treatment;
- Patient able to comply with the protocol;
- Patient must have signed a written informed consent form prior to any study specific procedures;
- Patient must be affiliated to a Social Health Insurance.
You may not qualify if:
- Male breast cancer;
- HER2-positive status (positivity defined as IHC3+ and/or FISH amplification \>2.2);
- Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥ 5 years and patient is deemed to be at low risk for recurrence;
- Active brain metastases or leptomeningeal disease; History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain;
- Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
- Significant cardiovascular disease, including any of the following:
- NYHA class III-IV congestive heart failure;
- Unstable angina pectoris or myocardial infarction within the past 6 months;
- Severe valvular heart disease;
- Ventricular arrhythmia requiring treatment.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included;
- Patients with known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone, or their excipients;
- Persistent toxicities ≥ grade 2 from any cause, except chemotherapy-induced alopecia and Grade 2 peripheral neuropathy;
- Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy;
- Any gastrointestinal disorder interfering with absorption of the study drug;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (36)
Ico - Site Paul Papin
Angers, France
Institut Sainte Catherine
Avignon, France
Chu - Hopital Jean Minjoz
Besançon, France
Institut Bergonie
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Chu de Brest - Hôpital Morvan
Brest, France
Centre Francois Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Ch Alpes Leman
Contamine-sur-Arve, France
Centre Georges-François Leclerc
Dijon, France
Chu de Grenoble - Hopital Michallon
Grenoble, France
Clinique Sainte Marguerite
Hyères, France
Chd de Vendee
La Roche-sur-Yon, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Ch de Mont de Marsan
Mont-de-Marsan, France
Centre Antoine Lacassagne
Nice, France
Chr D Orleans - Hopital La Source
Orléans, France
Hôpital Saint-Louis
Paris, France
Hôpital Tenon
Paris, France
Institut Curie - Hôpital Claudius Regaud
Paris, France
Ch de Perpignan
Perpignan, France
Ch Lyon Sud
Pierre-Bénite, France
CH de la Région d'Annecy
Pringy, France
Institut Jean Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Institut Curie - Hôpital René Huguenin
Saint-Cloud, France
Ico- Site Rene Gauducheau
Saint-Herblain, France
Centre Paul Strauss
Strasbourg, France
Hopital Civil - Strasbourg
Strasbourg, France
Hopitaux Du Leman
Thonon-les-Bains, France
Institut Claudius Regaud
Toulouse, France
Ch Bretagne Atlantique
Vannes, France
Hôpital Privé Océane
Vannes, France
Gustave Roussy Cancer Campus
Villejuif, France
Related Publications (1)
Bonnefoi H, Grellety T, Tredan O, Saghatchian M, Dalenc F, Mailliez A, L'Haridon T, Cottu P, Abadie-Lacourtoisie S, You B, Mousseau M, Dauba J, Del Piano F, Desmoulins I, Coussy F, Madranges N, Grenier J, Bidard FC, Proudhon C, MacGrogan G, Orsini C, Pulido M, Goncalves A. A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1). Ann Oncol. 2016 May;27(5):812-8. doi: 10.1093/annonc/mdw067. Epub 2016 Feb 18.
PMID: 27052658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hervé BONNEFOI, Prof.
Institut Bergonié Bordeaux
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
April 29, 2013
Study Start
July 1, 2013
Primary Completion
July 15, 2015
Study Completion
July 4, 2018
Last Updated
February 23, 2021
Record last verified: 2021-02