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

Breast Cancer Clinical Trial

— HER-ception  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400438
• Other study ID #: HER-ception
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: July 20, 2016
• Start date: July 2011
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. 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 ®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• questionnaires
delivery of questionnaires and self-psychological interview
• questionnaires
delivery of questionnaires and self-psychological interview

Locations

Country	Name	City	State
France	Centre François BACLESSE	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ®.	at 9 months	No
Secondary	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 ®	3, 6, 9 and 12 months	No
Secondary	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.	at 3, 6 ,9 and 12 months	No
Secondary	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.	at 3 months	No
Secondary	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.	at 6 months	No