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NCT Number: NCT01400438

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

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 ®.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre François BACLESSE

Caen, Calvados, 14076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

delivery of questionnaires and self-psychological interview

Primary outcomes

  1. score of fatigue

    Time frame: at 9 months

    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 outcomes

  1. Assess the quality of life

    Time frame: 3, 6, 9 and 12 months

    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 ®

  2. Impact of Herceptin ® in the professional lives

    Time frame: at 3, 6 ,9 and 12 months

    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.

  3. quantitative and qualitative psychological impact of Herceptin ®

    Time frame: at 3 months

    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.

  4. a qualitative sociological analysis among spouses of patients

    Time frame: at 6 months

    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.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study 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)

Acronym: HER-ception

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2011
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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