Clinical Trial Results:
Phase II study evaluating the toxicity and activity of the combination lapatinib + capecitabine in elderly patients aged 70 and over with metastatic breast cancer over expressing HER2
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Summary
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EudraCT number |
2009-015981-73 |
Trial protocol |
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Global end of trial date |
12 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Sep 2022
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First version publication date |
23 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 |
GERICO 09/0907
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Additional study identifiers
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ISRCTN number |
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US NCT number |
NCT01262469 | ||
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 |
12 Nov 2013
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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 |
12 Nov 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess clinical benefit (defined at 4 months as complete response, partial response or stable disease), safety and preserved geriatric independence. (main objective is a “bi-criteria” or composite criteria).
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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 study was conducted in accordance with the ethical principles that have their origins in the latest version of the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) on the conduct of clinical trials, and the applicable local regulatory requirements and laws (The Huriet Law N°88-1138 of the 20th December 1998 on the protection of persons taking part in biomedical research; The National Informatics and Freedoms Commission – Law N° 78-17 of the 6th January 1978 modified by the law N° 2004-801 of the 6th August 2004 concerning the protection of the person with regards to the use of personal data; Bioethical law N°2011-814 of the 8th July 2011).
Furthermore, independent Ethics Committees reviewed and gave favorable opinions to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients.
Written informed consent was obtained from all patients prior to enrollment.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
19 May 2010
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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: 4
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Worldwide total number of subjects |
4
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EEA total number of subjects |
4
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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) |
0
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
The GERICO 09 study was a multicentric phase II study evaluating the toxicity and activity of the combination of lapatinib+ capecitabine in locally advanced or metastatic breast cancer over expressing HER2 for patients aged ≥70 who have failed after one line of chemotherapy in combination with trastuzumab. | ||||||||||||
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Pre-assignment
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Screening details |
The study consisted of a 28-day screening phase (patients' eligibility and baseline measurements), a treatment phase (21-day cycle till disease progression or unacceptable toxicity), and a long-term follow-up to monitor the clinical benefit rate, time to progression, progression-free survival, overall survival, overall response, rate and safety | ||||||||||||
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Period 1
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Period 1 title |
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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Lapatinib plus capecitabine | ||||||||||||
Arm description |
Lapatinib was administrated orally at the dose of 1250 mg/day in combination with capecitabine. Capecitabine was administered at 850 mg/m² bi-daily from D1 to D14 of the first 21-cycle then, if no unacceptable toxicity was observed during the first cycle, at the dose of 1000 mg/m² bi-daily from D1 to D14 of subsequent 21-day cycles. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Lapatinib
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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 |
1250 mg/day, one hour before breakfast.
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Investigational medicinal product name |
Capecitabine
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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 |
First 21-day cycle: 850 mg/m² bi-daily from D1 to D14 during a meal (or within 30 minutes after), at breakfast and dinner.
Subsequent 21-day cycles: 1000 mg/m² bi-daily from D1 to D14 during a meal (or within 30 minutes after), at breakfast and dinner.
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lapatinib plus capecitabine
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Reporting group description |
Lapatinib was administrated orally at the dose of 1250 mg/day in combination with capecitabine. Capecitabine was administered at 850 mg/m² bi-daily from D1 to D14 of the first 21-cycle then, if no unacceptable toxicity was observed during the first cycle, at the dose of 1000 mg/m² bi-daily from D1 to D14 of subsequent 21-day cycles. | ||
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End point title |
Clinical benefit [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Benefit was defined at 4 months after inclusion as complete response, partial response, or stable disease.
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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: The study was halted prematurely with only 4 patients inlcuded. Thus, no statistical analysis was performed. |
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| Notes [2] - Due to early termination of the study with only 4 patients included, no analysis was performed |
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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 |
Overall period of the study (up to 2.5 years after inclusion)
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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 |
12
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Reporting groups
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Reporting group title |
Lapatinib plus capecitabine
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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21 Jan 2010 |
The inclusion criteria number 9 was modified. The minimum hemoglobin level was set up at 10 g/dl (instead of 9 g/dl) with this amendment. |
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18 Feb 2011 |
The inclusion criteria #7 was amended to allow for the recruitment of patients who would not have received trastuzumab. |
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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. | |||
| The study was stopped prematurely due to lack of recruitment (4 patients included. | |||
