Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+

NCT01220076 | Completed Phase 2

• 1 other identifier: BRD 08/11-A
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +. The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.

Conditions

Non Metastatic Breast Cancer

Keywords

Tamoxifen,; Breat Cancer; Pharmacogenetic; non metastatic breast cancer, HR +

Outcome Measures

Primary Outcomes (1)

• Evaluate the response to Tamoxifen treatment, in preoperative situations (immediately operable patients) in patients with positive Hormone Receptors (HR+) non-metastatic breast cancer

  The primary endpoint is the determination of the variation in the KI-67 expression, a marker of cell proliferation, at the tumour level between the initial biopsy (T0) and after 5 weeks of tamoxifen treatment, in relation to cytochrome 2D6 polymorphisms. A 50% geometric reduction in KI-67 expression at 5 to 7 weeks should be considered as a major response

  5 weeks

Study Arms (1)

Tamoxifene

EXPERIMENTAL

Drug: tamoxifen

Interventions

tamoxifen DRUG

Tamoxifene

Eligibility Criteria

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

You may qualify if:

• Adult Females (≥ 18 years), with effective contraception. The contraceptive should not use estrogen to a derivative. It must be continued during treatment with tamoxifen for at least two months after his arrest.
• Primary tumor hormonopositive: ER and / or PR ≥ 50% by immunohistochemistry.
• Lack of HER2 overexpression
• Palpable primary tumor or greater than or equal to 20 mm in diameter, measured by ultrasound
• Patient scheduled to undergo breast cancer surgery
• No metastases
• Clinical Stage M0
• Performance index ≤ 1 (OMS)
• Neutrophils WBC \> or = 1500 / mm3, Platelets \> or = 100 000/mm3 Hemoglobin ≥10 g/dL
• Normal liver function: bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases).
• Normal renal function (creatinine ≤ 1.5 mg / dL or creatinine clearance ≥ 60 mL / min)
• Cardiac function (MUGA scan or ultrasound February\> 55%) and lung function, 5.2.2 Criteria related to participation in the study:
• Patient affiliated to social security, Patient has signed and dated consent
• Pregnant or Breastfeeding women
• Use of St. John's Wort (herbal tea ...) within 5 days before starting treatment

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (3)

Centre Léon Berard

Lyon, 69000, France

Location

Institut Curie

Paris, France

Location

Institut de Cancerologie de l'Ouest (ICO)

Saint-Herblain, 44805, France

Location

MeSH Terms

Interventions

Tamoxifen

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: September 1, 2009
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

FR (3)