Clinical Trial Results:
Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response.
Summary
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EudraCT number |
2007-004216-31 |
Trial protocol |
FR |
Global end of trial date |
28 Mar 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Feb 2022
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First version publication date |
05 Feb 2022
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Other versions |
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 |
IB 2007-26
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00871858 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Institut Bergonié
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Sponsor organisation address |
229 cours de l'Argonne, Bordeaux, France, 33076
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Public contact |
Regulatory Affairs Management Desk, Institut Bergonié, drci@bordeaux.unicancer.fr
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Scientific contact |
Regulatory Affairs Management Desk, Institut Bergonié, drci@bordeaux.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 |
02 Jul 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Mar 2017
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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 |
Evaluate clinical tumor response at 6 months in patients with hormone-sensitive non-metastatic breast cancer treated with neoadjuvant anastrozole and fulvestrant.
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Protection of trial subjects |
A supervisory committee is constitued to evaluate the benefit/risk ratio along the study period.
A serious adverse event committee is constitued to review the safety cases
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Mar 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 120
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Worldwide total number of subjects |
120
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EEA total number of subjects |
120
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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) |
29
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From 65 to 84 years |
84
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85 years and over |
7
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
•Histologically confirmed invasive breast cancer, meeting 1 of the following criteria: ◦SBR grade I-II disease (patients < 65 years of age) ◦SBR grade I-III disease (patients > 65 years of age) •T2 (2-5 cm), T3, or T4B, and N0-1 disease •No metastatic disease •Breast lesion not amenable to breast-conserving resection •No inflammatory brea | ||||||||||||||||||||||||
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 |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A (ANA) | ||||||||||||||||||||||||
Arm description |
Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Anastrozole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.
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Arm title
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Arm B (FULV) | ||||||||||||||||||||||||
Arm description |
Patients received fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. | ||||||||||||||||||||||||
Arm type |
control | ||||||||||||||||||||||||
Investigational medicinal product name |
Fulvestrant
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Patients received fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fu
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Baseline characteristics reporting groups
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Reporting group title |
Arm A (ANA)
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Reporting group description |
Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B (FULV)
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Reporting group description |
Patients received fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Arm A (ANA)
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Reporting group description |
Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months | ||
Reporting group title |
Arm B (FULV)
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Reporting group description |
Patients received fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. |
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End point title |
Objective Response Rate (ORR) Determined by Clinical Palpation [1] | ||||||||||||
End point description |
Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.
Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
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End point type |
Primary
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End point timeframe |
6 months
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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 statistical test has been performed as it is a non-comparative clinical trial. Calculation of confidence interval. |
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No statistical analyses for this end point |
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End point title |
Objective response rate (ORR) determined by ultrasound | ||||||||||||
End point description |
Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.
Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
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End point type |
Secondary
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End point timeframe |
6 months
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No statistical analyses for this end point |
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End point title |
Objective response rate (ORR) determined by mammography | ||||||||||||
End point description |
Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.
Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
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End point type |
Secondary
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End point timeframe |
6 months
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No statistical analyses for this end point |
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End point title |
Rate of breast-conserving surgery | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
6 months
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No statistical analyses for this end point |
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End point title |
Percentage of Participants with 5-year Relapse-Free Survival | ||||||||||||
End point description |
Relapse-Free survival (RFS) is measured from the date of randomization to the date of the following events, whichever occurs first according to the DATECAN recommendations for breast cancer:
- Invasive ipsilateral breast tumor recurrence/ progression ;
- Local invasive recurrence/progression ;
- Regional invasive recurrence/progression (N+: regional progression) ;
- Appearance/Occurrence of Metastatic recurrence;
- Death whatever the cause.
Participants who did not experience events were censored at the date of last follow-up. RFS was estimated using the Kaplan-Meier method. No comparison test was performed between the two arms as this study is non-comparative.
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End point type |
Secondary
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End point timeframe |
5 years
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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 |
The adverse event are reported from the signature of the informed consent form to the study end participation of the patient
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
3.0
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Reporting groups
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Reporting group title |
Arm A (ANA)
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Reporting group description |
Experimental arm | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B (FULV)
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Reporting group description |
Control arm | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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15 Jul 2009 |
Protocol V3 dated 22-jun-2009 |
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07 Mar 2012 |
Protocol V4 dated 22-feb-2012 |
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04 Apr 2014 |
Protocol V5 dated 18-feb-2014 |
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/26171933 |