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

NCT ID: NCT01400438

Last Updated: 2016-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-09-30

Brief 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 ®.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

patients group with Herceptin

Patients beginning Herceptin in adjuvant after chemotherapy

Group Type: EXPERIMENTAL

questionnaires

Intervention Type: OTHER

delivery of questionnaires and self-psychological interview

Control group

patient not beginning Herceptin after chemotherapy : control group

Group Type: ACTIVE_COMPARATOR

questionnaires

Intervention Type: OTHER

delivery of questionnaires and self-psychological interview

Interventions

questionnaires

delivery of questionnaires and self-psychological interview

Intervention Type: OTHER

questionnaires

delivery of questionnaires and self-psychological interview

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne DELCAMBRE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

Centre François BACLESSE

Caen, Calvados, France

Countries

France

Other Identifiers

HER-ception

Identifier Type: -

Identifier Source: org_study_id