Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer - Full Text View

Sponsors and Collaborators:	Centre Val d'Aurelle - Paul Lamarque Novartis
Information provided by:	Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:	NCT00208273

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Letrozole - Concomitant Drug: Letrozole - Sequential	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:

Sub-cutaneous late toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Early toxicity
Lung late toxicity
Cosmetic results
Local failure
Relapse-free survival
Overall survival

Enrollment:	150
Study Start Date:	January 2005
Study Completion Date:	February 2007

Arms	Assigned Interventions
A: Experimental Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy.	Drug: Letrozole - Concomitant
B: Experimental Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy.	Drug: Letrozole - Sequential

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208273

Locations

France
CRLC Val d'Aurelle
MONTPELLIER, France, 34298

Sponsors and Collaborators

Centre Val d'Aurelle - Paul Lamarque

Novartis

Investigators

Principal Investigator:

David AZRIA, MD,PhD

CRLC Val d'Aurelle

More Information

Publications:

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. No abstract available.

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

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.

Azria D, Lemanski C, Zouhair A, Gutowski M, Belkacemi 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.

Study ID Numbers:	CO-HO-RT/2004/31
Study First Received:	September 13, 2005
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00208273
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:

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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009