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

This study is currently recruiting participants.
Verified June 2012 by Centre Francois Baclesse
Sponsor:
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01400438
First received: July 19, 2011
Last updated: December 14, 2012
Last verified: June 2012
History of Changes

July 19, 2011
December 14, 2012
July 2011
December 2013   (final data collection date for primary outcome measure)
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 ®.
Same as current
Complete list of historical versions of study NCT01400438 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 questionnary on professional lives, a scoring will be determinated

  • 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 questionnaries, a scoring will be determinated

  • 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 caracteristic sociologic of patients will be described.
Not Provided
Not Provided
 
Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer
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 ®.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Breast Cancer
Other: questionnaires
delivery of questionnaires and self-psychological interview
  • Experimental: patients group with Herceptin
    Patients beginning Herceptin in adjuvant after chemotherapy
    Intervention: Other: questionnaires
  • Active Comparator: Control group
    patient not beginning Herceptin after chemotherapy : control group
    Intervention: Other: questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
March 2015
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Corinne DELCAMBRE, MD 02 31 45 50 02 c.delcambre@baclesse.fr
Contact: Sabine NOAL, MD 02 31 45 50 02 s.noal@baclesse.fr
France
 
NCT01400438
HER-ception
No
Dr Corinne DELCAMBRE, Centre François BACLESSE
Centre Francois Baclesse
Not Provided
Principal Investigator: Corinne DELCAMBRE, MD Centre François Baclesse
Centre Francois Baclesse
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP