Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer (HER-ception)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01400438
First received: July 19, 2011
Last updated: July 3, 2014
Last verified: June 2012
  Purpose

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 ®.


Condition Intervention
Breast Cancer
Other: questionnaires

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • score of fatigue [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    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 ®.


Secondary Outcome Measures:
  • Assess the quality of life [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    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 ®

  • Impact of Herceptin ® in the professional lives [ Time Frame: at 3, 6 ,9 and 12 months ] [ Designated as safety issue: No ]

    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.


  • quantitative and qualitative psychological impact of Herceptin ® [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

    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.


  • a qualitative sociological analysis among spouses of patients [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 70
Study Start Date: July 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients group with Herceptin
Patients beginning Herceptin in adjuvant after chemotherapy
Other: questionnaires
delivery of questionnaires and self-psychological interview
Active Comparator: Control group
patient not beginning Herceptin after chemotherapy : control group
Other: questionnaires
delivery of questionnaires and self-psychological interview

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400438

Locations
France
Centre François BACLESSE
Caen, Calvados, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: Corinne DELCAMBRE, MD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Dr Corinne DELCAMBRE, Centre François BACLESSE
ClinicalTrials.gov Identifier: NCT01400438     History of Changes
Other Study ID Numbers: HER-ception
Study First Received: July 19, 2011
Last Updated: July 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
Herceptin
Breast cancer
Quality of life
fatigue

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014