TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention (TSARINE)

Centre Oscar Lambret

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Metastasis; Sur-expressing Her2-neu

Treatments: Drug: Other chemotherapy in association with Trastuzumab; Drug: Trastuzumab; Radiation: cerebral prophylactic radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01613482

TSARINE 0602

Details and patient eligibility

About

Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH)
• Visceral metastasis, only or multiple
• First line metastasis treatment by Trastuzumab in association with chemotherapy
• Good general conditions: OMS=<2 or Karnofsky >=70%
• Age > 18 years and < 70 years
• Life expectancy >=3 mois
• No Trastuzumab since more of 6 months
• No cerebral metastasis (MRI)
• Efficacy contraception for women with genital capacities
• Consent signed by the patient

Exclusion Criteria

• Contraindication to IRM
• Psychiatric decease
• Prior cerebral radiotherapy,
• Geographical constraint, compromising the fallow of patients
• Infectious or other serious pathology, likely to stop the treatment
• Positive serology (HIV, hBC, hBS)
• Inclusion in an other clinical trial or in the 4 weeks before th inclusion
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

13 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Without cerebral prophylactic radiation

Treatment:

Drug: Other chemotherapy in association with Trastuzumab

Drug: Trastuzumab

Arm B

Experimental group

Description:

With cerebral prophylactic radiation

Treatment:

Drug: Other chemotherapy in association with Trastuzumab

Radiation: cerebral prophylactic radiation

Drug: Trastuzumab