Breast NeoplasmsEPTTCSMNCT03979911
Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
An observational study of Breast Neoplasms and HER-2 Gene Amplification, run by University Hospital, Brest at 1 site in France.
Trial summary
This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, HER-2 Gene Amplification
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2019to 22 Jul 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with metastatic breast cancer HER2 positive who received pertuzumab in combination with trastuzumab and taxane chemotherapy
Who may be able to join
- metastatic breast cancer
- HER2 positive
- Received pertuzumab in combination with trastuzumab and taxane chemotherapy
Who cannot join
- no HER2-positive breast cancer
- no association with taxane chemotherapy
- no metastatic breast cancer
- refusal to consent
Trial locations and contacts
1 site in 1 country.
Paul Bore contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Hélène SIMON, helene.simon@chu-brest.fr
About this study
Official title: Evaluation of Double HER2 Blocking by Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.
Read the detailed description
In 2013 the European Medicines Agency authorized the use of a new antibody named Pertuzumab in combination with Trastuzumab in first-line setting for patients with HER2-positive metastatic breast cancer. The efficacy and the safety were demonstrated in the CLEOPATRA study. This study had inclusion and exclusion criteria that might not be representative of a real life population of women with metastatic breast cancer. Few study tried to evaluate this treatment in real life settings but with discordant results. This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.
- Conditions
- Breast Neoplasms, HER-2 Gene Amplification
- Keywords
- Pertuzumab, Breast Neoplasms/pathology, Real life, Trastuzumab, Receptor, ErbB-2/antagonists & inhibitors*, Breast Neoplasms/drug therapy*, Multicenter Study, Taxoids, Antibodies, Monoclonal, Humanized
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
time between inclusion and progression of the disease
Measured: through study completion, an average of 1 year
overall survival
time between inclusion and death
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
comparison of the age of our population to those of the CLEOPATRA cohort
% of patients with an age <65 years and > 65 years and <75 years and > 75 years in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort
% of patients with adjuvant or neo-adjuvant chemotherapy in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort
% of patients with visceral metastasis in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort
% of patients with brain metastasis in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort
% of patients with positive hormonal receptors in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
comparison of the % of patients who had amplication of HER 2 detected in immunohistochemistry in our population to those of the CLEOPATRA cohort
% of patients with an amplication of HER 2 detected in immunohistochemistry in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
comparison of the % of patients who had a performance status >1 in our population to those of the CLEOPATRA cohort
% of patients with a performance status >1 in our study are compared to those of Cleopatra cohort
Measured: at the inclusion
safety of the treatment: % of patient with an adverse event under treatment with grade >2 according to CTCAE
% of patient with an adverse event under treatment with grade >2 according to CTCAE
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start22 Jan 2019
- Primary completion22 Jul 2019 (estimated)
- Study completion22 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979911
- Sponsor's protocol ID
- EPTTCSM (239BRC18.0129)
- Acronym
- EPTTCSM
- Status last verified
- Nov 2018
- First submitted
- 17 Apr 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Double HER2 Blocking by Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03979911
- Acronym / sponsor ID
- EPTTCSM / EPTTCSM (239BRC18.0129)
- Conditions
- Breast Neoplasms, HER-2 Gene Amplification
- Keywords
- Pertuzumab, Breast Neoplasms/pathology, Real life, Trastuzumab, Receptor, ErbB-2/antagonists & inhibitors*, Breast Neoplasms/drug therapy*, Multicenter Study, Taxoids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 22 Jul 2019 (estimated)
- Study completion
- 22 Jul 2019 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.
Detailed description
In 2013 the European Medicines Agency authorized the use of a new antibody named Pertuzumab in combination with Trastuzumab in first-line setting for patients with HER2-positive metastatic breast cancer. The efficacy and the safety were demonstrated in the CLEOPATRA study. This study had inclusion and exclusion criteria that might not be representative of a real life population of women with metastatic breast cancer. Few study tried to evaluate this treatment in real life settings but with discordant results. This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with metastatic breast cancer HER2 positive who received pertuzumab in combination with trastuzumab and taxane chemotherapy
Key inclusion criteria (3 listed)
- metastatic breast cancer
- HER2 positive
- Received pertuzumab in combination with trastuzumab and taxane chemotherapy
Key exclusion criteria (4 listed)
- no HER2-positive breast cancer
- no association with taxane chemotherapy
- no metastatic breast cancer
- refusal to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: through study completion, an average of 1 year
time between inclusion and progression of the disease
overall survival
Time frame: through study completion, an average of 1 year
time between inclusion and death
8 secondary outcomes
comparison of the age of our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
comparison of the % of patients who had a previous chemotherapy in our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
comparison of the % of patients who had visceral metastasis in our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
comparison of the % of patients who had brain metastasis in our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
comparison of the % of patients who had positive hormonal receptors in our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
comparison of the % of patients who had amplication of HER 2 detected in immunohistochemistry in our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
comparison of the % of patients who had a performance status >1 in our population to those of the CLEOPATRA cohort
Time frame: at the inclusion
safety of the treatment: % of patient with an adverse event under treatment with grade >2 according to CTCAE
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Bore contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and HER-2 Gene Amplification, run by University Hospital, Brest at 1 site 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helene SIMON (02-98-22-34-51, helene.simon@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2019.