Clinical trial · Interventional
Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patients group with Herceptin
- description
- Patients beginning Herceptin in adjuvant after chemotherapy
- interventionNames
- Other: questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- patient not beginning Herceptin after chemotherapy : control group
- interventionNames
- Other: questionnaires
Primary outcomes (1)
- measure
- score of fatigue
- timeFrame
- at 9 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available