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A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors


This trial is an open-label randomized multicenter phase II study.

A ratio of 1 to 1 will be used for the randomization process between the two arms:

- Arm A : Letrozole 2.5 mg daily for 5 years started three weeks before the first day of
adjuvant radiotherapy.

- Arm B : Letrozole 2.5 mg daily for 5 years started three weeks after the last day of
adjuvant radiotherapy.

All patients will be followed every 3 months for toxicities, disease status and for survival
until death.


Inclusion Criteria:



- Compliant postmenopausal women

- Conservative breast cancer surgery

- Extension evaluation of disease will be proven negative

- Patients with tumor negative margins

- Patients will be classified as T1, T2, T3; Sentinel node negative, N0, N1 or N2; M0.

- Receptor positive tumors (ER and/or PgR = 10 fmol/mg cytosol protein; or = 10% of the
tumor cells positive by immunocytochemical evaluation).

- Adequate marrow function (polynuclear neutrophils >= 1200.10^9/l, platelets >=
100.10^9/l, and hemoglobin >= 10 g/dl).

- Hepatic function (bilirubin >= 30 µmol/l, ALT (SGPT) or AST (SGOT) >= 1.5 x upper
limit of the institution) and cholesterol level <2 x upper limit of the institution.

- Must be geographically accessible for follow-up.

- Written and dated informed consent

Exclusion Criteria:

- Patients with distant metastases.

- Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal
or lobular, of the contralateral breast.

- Patients staged T4 or N3 or treated by not conservative surgery (radical mastectomy).

- Patients with neoadjuvant chemotherapy or hormonal therapy.

- Patients with previous or concomitant other (not breast cancer) malignancy within the
past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin
or in situ carcinoma of the cervix. Patients who have had a previous other malignancy
must have been disease free for at least five years.

- Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic,
lung embolism, etc.) which would prevent prolonged follow-up.

- Patients treated with systemic investigational drugs within the past 30 days.

- Breast cancer chemoprevention with anti-estrogens

- Hormone replacement therapy (HRT) not stopped at least 4 weeks before randomization

- Patients known to be HIV positive (no specific tests are required to determine the
eligibility).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sub-cutaneous late toxicity

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

David AZRIA, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle

Authority:

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

Study ID:

CO-HO-RT/2004/31

NCT ID:

NCT00208273

Start Date:

January 2005

Completion Date:

February 2007

Related Keywords:

  • Breast Cancer
  • Postmenopausal breast cancer, radiohormonotherapy sequences
  • ER+ and/or PgR+,
  • Postmenopausal Breast cancer,
  • Adjuvant setting
  • Breast Neoplasms

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