NCT01400438

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 ®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

3.8 years

First QC Date

July 19, 2011

Last Update Submit

July 20, 2016

Conditions

Breast Cancer

Keywords

HerceptinBreast cancerQuality of lifefatigue

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Assess the quality of life

    3, 6, 9 and 12 months

  • Impact of Herceptin ® in the professional lives

    at 3, 6 ,9 and 12 months

  • quantitative and qualitative psychological impact of Herceptin ®

    at 3 months

  • a qualitative sociological analysis among spouses of patients

    at 6 months

Study Arms (2)

patients group with Herceptin

EXPERIMENTAL

Patients beginning Herceptin in adjuvant after chemotherapy

Other: questionnaires

Control group

ACTIVE COMPARATOR

patient not beginning Herceptin after chemotherapy : control group

Other: questionnaires

Interventions

questionnairesOTHER

delivery of questionnaires and self-psychological interview

patients group with Herceptin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François BACLESSE

Caen, Calvados, 14076, France

Location

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Corinne DELCAMBRE, MD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 22, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

FR(1)