FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole

NCT00199134 | Completed Phase 2 DMC

• 1 other identifier: FRAGRANCE
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;

Conditions

Breast Cancer

Keywords

neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Response Rate Pathologic complete response rate

  at the end of the study

Study Arms (1)

Letrozole

OTHER

Letrozole 2.5 mg per day

Drug: Letrozole

Interventions

Letrozole DRUG

Size of the tumor is followed

Letrozole

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• Post-menopausal(no age limit) defined as:
• Radiation-induced menopause or surgical bilateral oophorectomy, or
• Women with an intact uterus and
• i. \> 55 years of age or ii. without menses for the last 5 years or iii. £ 55 years of age and has not had menses for at least the last 12 months (but has had menses in the last 5 years) and has postmenopausal levels of FSH c. Women without an intact uterus and i. \> 55 years of age or ii. £ 55 years of age and has postmenopausal levels of FSH
• Contraindications for the use of neoadjuvant/adjuvant chemotherapy, refusal by the patient to receive chemotherapy or if the investigator believes the patient is a suitable candidate for this protocol.
• WHO performance status \< 1
• Histologically-confirmed ductal or lobular operable adenocarcinoma of the breast (stage I, II and III)
• Confirmed absence of liver, lung and bone metastases.
• Primary tumor of at least 2 cm, measured clinically and/or radiologically
• Multifocal invasive tumors are not eligible, unless a biopsy showing ER positivity can be obtained from each tumor lesion.
• ER-positive and/or PgR-positive tumors, defined according to immunohistochemistry (i.e. \> 10% of positive cells after immunostaining), if woman younger 70 years; ER-positive or PgR-positive tumors if woman older than 70 years.
• Fixed and frozen samples from the primary tumor, obtained before treatment, must be available for evaluation of biological markers (cDNA microarrays, EGFR, HER-2, intra-tumoral aromatase).
• No concurrent second malignancy, including contralateral breast cancer (exceptions are: adequately treated basal cell carcinoma of the skin and in situ carcinoma of the cervix). Any prior second malignancy must be in remission for ³ 5 years.
• No other serious illness or medical condition including:

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Feculdade de Medicina da Universidade de Sao Paulo - Brasil: collaborator
• Hospital de Clinicas de Porto Alegre: collaborator
• Hospital do Cancer, Sao Paulo: collaborator

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christos Sotiriou, MD, PhD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 6, 2015

Record last verified: 2014-12

Locations

BE (1)