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Breast CancerPhase 2AMANCT01842321

Abiraterone Acetate in Molecular Apocrine Breast Cancer

A Phase 2 study testing Abiraterone Acetate in people with Breast Cancer, run by UNICANCER at 36 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Abiraterone Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
36 sitesFrance
Study dates
Jul 2013to 4 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged ≥18 years;
  • Histologically confirmed locally advanced or metastatic breast cancer;
  • Triple negative breast cancer:
  • Estrogen receptor (ER)-negative and Progesterone receptor (PR)-negative, as defined by a <10 % tumour stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from either primary or metastatic breast cancer site;
  • Androgen receptor (AR)-positive, as defined centrally by a ≥10% tumour stained cells by IHC (AR assessment by local pathologist before inclusion is not mandatory);
  • 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);
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  • 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;
  • Systolic blood pressure (BP) <160 mm Hg and diastolic BP <95 mm Hg, as documented on inclusion day (Hypertension at baseline assessment allowed provided it is currently controlled under anti-hypertensive drugs);
  • Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion;
  • If receiving a bisphosphonate or denosumab, dose must have been stable for at least 2 doses before inclusion;
  • 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.

Who cannot join

  • 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:
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  • 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;
  • Difficulties with swallowing study capsules;
  • Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) within the last 3 weeks (2 weeks for oral or weekly CT ; 6 weeks for nitrosoureas and mitomycin C), or other investigational agents ; Concurrent palliative radiotherapy allowed;
  • Concurrent enrolment in another clinical trial in which investigational therapies are administered;
  • Pregnant women, women who are likely to become pregnant or are breast-feeding;
  • Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
  • Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol;
  • Individual deprived of liberty or placed under the authority of a tutor.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

France36 sites

  • Ico - Site Paul Papin

    Angers

  • Institut Sainte Catherine

    Avignon

  • Chu - Hopital Jean Minjoz

    Besançon

  • Institut Bergonie

    Bordeaux

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux

  • Chu de Brest - Hôpital Morvan

    Brest

  • Centre Francois Baclesse

    Caen

  • Centre Jean Perrin

    Clermont-Ferrand

  • Ch Alpes Leman

    Contamine-sur-Arve

  • Centre Georges-François Leclerc

    Dijon

  • Chu de Grenoble - Hopital Michallon

    Grenoble

  • Clinique Sainte Marguerite

    Hyères

  • Chd de Vendee

    La Roche-sur-Yon

  • Centre Oscar Lambret

    Lille

  • Centre Leon Berard

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Ch de Mont de Marsan

    Mont-de-Marsan

  • Centre Antoine Lacassagne

    Nice

  • Chr D Orleans - Hopital La Source

    Orléans

  • Hôpital Saint-Louis

    Paris

  • Hôpital Tenon

    Paris

  • Institut Curie - Hôpital Claudius Regaud

    Paris

  • Ch de Perpignan

    Perpignan

  • Ch Lyon Sud

    Pierre-Bénite

  • CH de la Région d'Annecy

    Pringy

  • Institut Jean Godinot

    Reims

  • Centre Henri Becquerel

    Rouen

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud

  • Ico- Site Rene Gauducheau

    Saint-Herblain

  • Centre Paul Strauss

    Strasbourg

  • Hopital Civil - Strasbourg

    Strasbourg

  • Hopitaux Du Leman

    Thonon-les-Bains

  • Institut Claudius Regaud

    Toulouse

  • Ch Bretagne Atlantique

    Vannes

  • Hôpital Privé Océane

    Vannes

  • Gustave Roussy Cancer Campus

    Villejuif

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

Screening : All women 18+, with a confirmed locally advanced or metastatic Triple Negative Breast Cancer (TNBC), will be screened and invited to participate (300-500 patients).

Only patients with a centralized confirmation of ER-/PR-/HER2- and evaluation of AR+ will be included and treated with abiraterone acetate plus prednisone (31 patients).

The Treatment phase comprises a series of 4 weeks-cycles with continuous study treatment. Study drug treatment will continue until the earliest of the following events: disease progression, unacceptable toxicity, or death.

At disease progression, patients must be discontinued from study drug and should be evaluated within 30 days during the Post treatment visit and then entered into the Follow-Up phase.Patients should enter the Follow-Up Period regardless of reason for study drug discontinuation and should be monitored every 3 months (± 7 days) during 2 years.

Conditions
Breast Cancer
Being tested
Abiraterone Acetate
Keywords
locally advanced, metastatic, Breast Cancer, Molecular Apocrine, HER2-negative, Abiraterone acetate
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone AcetateDrug

    Also called ZYTIGA

    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.

Study groups in NCT01842321
Study groupRoleWhat they receive
Abiraterone AcetateExperimentalNot described
Receives: Drug: Abiraterone Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: at 6 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    The Objective response is defined as complete response (CR) or partial response (PR) according to RECIST criteria v1.1

    Measured: at 6 months

  2. Duration of overall response (DoR)

    The DoR is defined as the time from documentation of tumour response (CR/PR whichever is first recorded) to disease progression, according to RECIST criteria v1.1.

    Measured: at 6 months

  3. Overall Survival (OS)

    The OS is defined as the time from the first administration of abiraterone acetate to death from any cause.

    Measured: median follow-up = 2 years

  4. Progression-free survival (PFS)

    The PFS is defined as the time from the first administration of abiraterone acetate to progression or death of any cause, whichever occurs first.

    Measured: median follow-up = 2 years

  5. Overall safety profile

    The overall safety profile of the treatment is determined by the occurrence of adverse events and toxicities. The severity of the adverse events and toxicities will be graded according the NCI CTCAE scale version 4.0.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion15 Jul 2015
  4. Study completion4 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842321
Sponsor's protocol ID
CADUSEIME02
Other IDs
2012-002525-29, UC-0140/1206
Acronym
AMA
Status last verified
Feb 2021
First submitted
24 Apr 2013
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27052658

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate in people with Breast Cancer, run by UNICANCER at 36 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit rate (CBR) (time frame: at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.

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