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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)


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

score of fatigue

Outcome Description:

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 ®.

Outcome Time Frame:

at 9 months

Safety Issue:

No

Principal Investigator

Corinne DELCAMBRE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

HER-ception

NCT ID:

NCT01400438

Start Date:

July 2011

Completion Date:

March 2015

Related Keywords:

  • Breast Cancer
  • Herceptin
  • Breast cancer
  • Quality of life
  • fatigue
  • Breast Neoplasms

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