Breast CancerHER-ceptionNCT01400438
Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer
A study testing questionnaires in people with Breast Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. 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?
- questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Sep 2015
- Phase
- Interventional
- 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 over 18
- Invasive breast carcinoma confirmed histologically
- Non-metastatic cancer
- Surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
- Patient should receive their last course of adjuvant chemotherapy (3 FEC and 3 Taxotere)
- Patients not receiving the third course of Taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of Taxotere
Show all 10Show fewer
- For the group Herceptin ®: HER2 overexpression without contraindication to treatment administration
- For the control group: no indication for Herceptin ®
- Radiation therapy and / or adjuvant hormonal therapy allowed
- Free and informed consent signed
Who cannot join
- Women under 18 or over 60 years
- Histology other than adenocarcinoma
- Metastatic Breast Cancer
- Chemotherapy neoadjuvant
- Surgery of the primary tumor unrealized
- Lack of adjuvant chemotherapy with Taxotere 3 FEC and 3
Show all 10Show fewer
- Patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
- Patient under guardianship or unable to give informed consent,
- Pregnant or lactating
- Patient unable to undergo a medical for geographical, social or psychopathological
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer: Fatigue and Quality of Life During and Waning of Treatment, Psychosocial Aspects (Environment, Work)
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.
The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.
- Conditions
- Breast Cancer
- Being tested
- questionnaires
- Keywords
- Herceptin, Breast cancer, Quality of life, fatigue
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
delivery of questionnaires and self-psychological interview
questionnairesOther
delivery of questionnaires and self-psychological interview
| Study group | Role | What they receive |
|---|---|---|
| patients group with Herceptin | Experimental | Patients beginning Herceptin in adjuvant after chemotherapy Receives: Other: questionnaires |
| Control group | Active comparator | patient not beginning Herceptin after chemotherapy : control group Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of fatigue
The main objective of this study is to evaluate the score of fatigue in patients with HER2 overexpressing breast cancer and for whom Herceptin ® treatment is prescribed, compared with a population of patients treated with the same age the same chemotherapy without Herceptin ®.
Measured: at 9 months
Secondary outcomes (4)
Assess the quality of life
Assess the quality of life of patients treated for breast cancer with surgery followed by adjuvant chemotherapy (+/-hormonotherapy) associated with treatment with Herceptin ®, compared with patients of similar age treated with the same chemotherapy without Herceptin ®
Measured: 3, 6, 9 and 12 months
Impact of Herceptin ® in the professional lives
Assess the impact of Herceptin ® in the professional lives of patients, compared to patients not treated with Herceptin ®.
Evaluation done by a specific questionnaire on professional lives, a scoring will be determined.
Measured: at 3, 6 ,9 and 12 months
quantitative and qualitative psychological impact of Herceptin ®
Assess the quantitative and qualitative psychological impact of Herceptin ® in patients so treated, compared to patients not treated with Herceptin ®.
Evaluation done by specific questionnaires, a scoring will be determined.
Measured: at 3 months
a qualitative sociological analysis among spouses of patients
Conduct a qualitative sociological analysis among spouses of patients treated with Herceptin ®.
An interview with a sociologist will be done and characteristic sociologic of patients will be described.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne DELCAMBRE, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400438
- Sponsor's protocol ID
- HER-ception
- Acronym
- HER-ception
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2011
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer: Fatigue and Quality of Life During and Waning of Treatment, Psychosocial Aspects (Environment, Work)
- ClinicalTrials.gov ID
- NCT01400438
- Acronym / sponsor ID
- HER-ception / HER-ception
- Conditions
- Breast Cancer
- Keywords
- Herceptin, Breast cancer, Quality of life, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jul 2011 (estimated)
- 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.
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.
The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients group with Herceptin | Experimental | Other: questionnairesPatients beginning Herceptin in adjuvant after chemotherapy |
| Control group | Active comparator | Other: questionnairespatient not beginning Herceptin after chemotherapy : control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged over 18
- Invasive breast carcinoma confirmed histologically
- Non-metastatic cancer
- Surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
- Patient should receive their last course of adjuvant chemotherapy (3 FEC and 3 Taxotere)
Key exclusion criteria (10 listed)
- Women under 18 or over 60 years
- Histology other than adenocarcinoma
- Metastatic Breast Cancer
- Chemotherapy neoadjuvant
- Surgery of the primary tumor unrealized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesdelivery of questionnaires and self-psychological interview | Other | patients group with Herceptin |
| questionnairesdelivery of questionnaires and self-psychological interview | Other | Control group |
Primary outcome
score of fatigue
Time frame: at 9 months
The main objective of this study is to evaluate the score of fatigue in patients with HER2 overexpressing breast cancer and for whom Herceptin ® treatment is prescribed, compared with a population of patients treated with the same age the same chemotherapy without Herceptin ®.
4 secondary outcomes
Assess the quality of life
Time frame: 3, 6, 9 and 12 months
Impact of Herceptin ® in the professional lives
Time frame: at 3, 6 ,9 and 12 months
quantitative and qualitative psychological impact of Herceptin ®
Time frame: at 3 months
a qualitative sociological analysis among spouses of patients
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Corinne DELCAMBRE, MD principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires in people with Breast Cancer, run by Centre Francois Baclesse 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 10 inclusion and 10 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 21 Jul 2016. 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?
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?
score of fatigue (time frame: at 9 months). 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 21 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.