Clinical Trial Results:
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.
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Summary
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EudraCT number |
2012-002525-29 |
Trial protocol |
FR |
Global end of trial date |
15 Jul 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Sep 2022
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First version publication date |
24 Sep 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
UC-0140/1206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01842321 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UNICANCER
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Sponsor organisation address |
101 RUE DE TOLBIAC, PARIS, France, 75013
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Public contact |
Nourredine AIT RAHMOUNE, UNICANCER, +33 171936704, n.ait-rahmoune@unicancer.fr
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Scientific contact |
Nourredine AIT RAHMOUNE, UNICANCER, +33 171936704, n.ait-rahmoune@unicancer.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Jul 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Jul 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To estimate antitumor activity of abiraterone acetate, as measured by the 6 months clinical benefit rate (CBR) in molecular apocrine HER2-negative locally advanced or metastatic breast cancer.
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Protection of trial subjects |
In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was performed in compliance with the principles laid down in the declaration of Helsinki, good Clinical
Practice and European regulation.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Jun 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
24 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 34
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Worldwide total number of subjects |
34
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EEA total number of subjects |
34
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
15
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85 years and over |
1
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Recruitment
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Recruitment details |
Recruitment only in France, Date of first inclusion: 26-Jun-2013 Date of last inclusion: 24-Dec-2014 | ||||||||||||
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Pre-assignment
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Screening details |
All women 18+, with a confirmed locally advanced or metastatic Triple Negative Breast Cancer (TNBC), will be screened and invited to participate. Only patients with a centralized confirmation of ER-/PR-/HER2- and evaluation of AR+ were included. | ||||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Abiraterone Acetate | ||||||||||||
Arm description |
Only one arm in this trial Treatment: abiraterone acetate plus prednisone | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
ABIRATERONE
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
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
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
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End points reporting groups
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Reporting group title |
Abiraterone Acetate
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Reporting group description |
Only one arm in this trial Treatment: abiraterone acetate plus prednisone | ||
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End point title |
Primary endpoint [1] | ||||||
End point description |
CBR is defined as:
• Numerator: total number of patients who show a complete response (CR), partial response (PR), or stable disease (SD) for ≥6 months.
• Denominator: total number of assessable patients for the primary endpoint
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End point type |
Primary
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End point timeframe |
The primary endpoint was the clinical benefit rate (CBR) defined as the percentage of patients who had a complete response (CR), partial response, or stable disease (SD) ≥6 months, according to RECIST v1.1.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statiscal analyses for the primary end point. A single stage study design was used to discriminate between a 15 and 35% clinical benefit rate (CBR). |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Reporting from the signing of the 1st consent form, until 30 days following the last administration of the experimental treatment
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Adverse event reporting additional description |
Occurrences all number for each non serious adverse event is not available. the number of subject affected by the non serious adverse event is reported in the "Occurrences all number" field.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
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Reporting groups
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Reporting group title |
all patients
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Dec 2013 |
This translational research program is aiming
1. To validate or identify a “molecular apocrine signature” using a variety of methods including a RT-qPCR (ER, AR, FOXA1 and 5 genes involved in the AR pathway) and IHC markers (ER, PR, HER2, CK5/6, CK17, EGFR, Ki67, AR, FOXA1 et GCDFP15) which identified molecular apocrine tumours with an excellent accuracy in a recent publication (Lehmann-Che J BCR 2013). In their series androgen receptors (AR) assessment by immunohistochemistry (IHC) was negative in 42% of molecular apocrine tumours (defined by expression arrays). In AMA trial (Caduseime 02) we will not change the first inclusion criteria which is “molecular apocrine tumour defined by IHC” but we will analyse by RT-PCR quantitative and IHC as mentioned above in tumour samples from eligible patients, and non-eligible patients (meaning not
identified as molecular apocrine after central review with standard IHC analysis including AR). The identification of a “molecular apocrine signature” with a high accuracy should have important consequences for patient selection in further trials. |
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16 May 2014 |
The protocol and the information sheet were updated in order to take into account last modifications on investigator's brochure |
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07 Jan 2015 |
clarifications made to an inclusion criterion and to the main evaluation criterion |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Occurrences all number for each non serious adverse event is not available. the number of subject affected by the non serious adverse event is reported in the "Occurrences all number" field. | |||
