Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208273
• Other study ID #: CO-HO-RT/2004/31
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: February 2007

Study information

• Verified date: December 2007
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will compare grade 2 or greater late skin toxicities of concomitant letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for postmenopausal women with receptor (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive tumors. Each drug will be prescribed for 5 years.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole - Concomitant

• Letrozole - Sequential

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle	Novartis

Country where clinical trial is conducted

France, 

References & Publications (4)

Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. — View Citation

Azria D, Larbouret C, Cunat S, Ozsahin M, Gourgou S, Martineau P, Evans DB, Romieu G, Pujol P, Pèlegrin A. Letrozole sensitizes breast cancer cells to ionizing radiation. Breast Cancer Res. 2005;7(1):R156-63. Epub 2004 Dec 7. — View Citation

Azria D, Lemanski C, Zouhair A, Gutowski M, Belkacémi Y, Dubois JB, Romieu G, Ozsahin M. [Adjuvant treatment of breast cancer by concomitant hormonotherapy and radiotherapy: state of the art]. Cancer Radiother. 2004 Jun;8(3):188-96. Review. French. — View Citation

Azria D, Pelegrin A, Dubois JB, Mirimanoff RO, Ozsahin M. Radiation therapy and tamoxifen: concurrent or sequential? It's no longer the question! J Clin Oncol. 2005 Jun 20;23(18):4239-41; author reply 4241-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sub-cutaneous late toxicity		2 years
Secondary	Early toxicity
Secondary	Lung late toxicity
Secondary	Cosmetic results
Secondary	Local failure
Secondary	Relapse-free survival
Secondary	Overall survival