Advertisement

Topics

An Observational Study to Assess Response to Tamoxifen

2014-07-23 21:13:32 | BioPortfolio

Summary

CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for measurable estrogen-receptor positive breast cancers. The primary endpoint is the difference in efficacy of tamoxifen, defined as the objective response rate using RECIST criteria, between women with a normal versus low Tamoxifen Activity Score (TAS) after 3-6 months of tamoxifen use. The TAS score is based on the presence of genetic variations and drug interactions. Secondary endpoints are time to progression, clinical benefit, serum metabolite concentrations, endometrial changes and menopausal symptoms. Patients using tamoxifen in the neoadjuvant setting needs being operated between 4-6 months following the start of tamoxifen.

Description

This multi-centre open label single arm non randomized observational study will compare the efficacy in terms of overall response rate and progression free survival of tamoxifen as first line therapy in 3 groups of postmenopausal women with measurable hormone dependent large, locally advanced or metastatic breast cancer. The 3 groups are women with a normal and those with a low 'tamoxifen activity score' based on genetic polymorphisms for CYP2D6 and other genes that are important in the metabolism of tamoxifen using SEQUENOM's MassARRAY technology.

The study is subject to Ethical Commission approval and patient consent. The study will necessitate collection of blood for genetic analyses.

We will investigate the relation between the studied genotype, the use of drugs that interfere with tamoxifen and tamoxifen-related endpoints like regression of metastatic or locally advanced or large oestrogen receptor positive breast cancer in tamoxifen users. The 'tamoxifen activity score' has been used by a group in the US showing a link with tamoxifen compliance. The score will be adapted to the Belgian situation based on the prevalence of polymorphism in a Belgian population. The efficacy of tamoxifen will be correlated with a predefined 'tamoxifen activity score' which is based on the presence of single nucleotide polymorphisms (SNP) in relevant genes combined with the effect of well known drugs that interfere with the metabolism of tamoxifen.

The study will be conducted in several clinical sites in Belgium. All patients will receive tamoxifen 20mg daily. Patients with a large operable or inoperable non-metastatic breast cancer will be considered for surgery no more than 4 months on tamoxifen. If operable, they will postoperatively receive the most appropriate adjuvant therapy and for hormone therapy either continue tamoxifen or receive an oral aromatase inhibitor as decided by the clinician. If women with a locally advanced inoperable breast cancer are not operable after the 4 months of neo-adjuvant therapy, another appropriate salvage therapy will be proposed. Women with metastatic breast cancer will continue treatment until clinical or imaging progression or unacceptable toxicity development. Patients that experience progression of their disease as defined by RECIST criteria will receive salvage therapy by an oral aromatase inhibitor if tamoxifen is given in first line but some patients may require another therapy like chemotherapy. The study will require approximately 14 months to recruit and another 7 months to events/data analyses as the estimated time to progression in this setting is 9-12 months if tamoxifen is given as first line endocrine therapy for those in the metastatic setting

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Breast Neoplasm

Location

Imelda ziekenhuis
Bonheiden
Antwerpen
Belgium
2820

Status

Recruiting

Source

Vlaamse Vereniging voor Obstetrie en Gynaecologie

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:32-0400

Clinical Trials [2089 Associated Clinical Trials listed on BioPortfolio]

Optimizing Preventative Adjuvant Linac-Based Radiation: the OPAL Trial A Phase II Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer

The goal of this clinical research study is to learn about the side effects that may occur after radiation is given to breast cancer patients for 2 to 2½ weeks at the part of the breast w...

Phase 1 Study of DS-8201a in HER-2 Breast Cancer Patients

This study will look at the effect of DS-8201a on heart rate and the movement of the drug through the body (pharmacokinetics) in participants with a certain type of breast cancer (HER2).

Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer

The two drugs used to treat metastatic breast cancer in this study may perform better when used together than when used separately. The use of another drug that prevents the most common s...

Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer

This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based che...

[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer [18F]fluoro...

PubMed Articles [3390 Associated PubMed Articles listed on BioPortfolio]

Solitary fibrous tumor of the breast: A rare neoplasm.

Effect of resveratrol on doxorubicin resistance in breast neoplasm cells by modulating PI3K/Akt signaling pathway.

In the study, we probed into the effect of Resveratrol (RES) on Doxorubicin (DOX)-resistant breast neoplasm cell line MCF-7/DOX as well as the mechanism of RES underlying the DOX-resistant breast canc...

Primary Mammary Analog Secretory Carcinoma (MASC) of the Vulva With ETV6-NTRK3 Fusion: A Case Report.

Mammary analog secretory carcinoma is a primary salivary gland neoplasm with histologic, immunophenotypic, and molecular features identical to those of secretory carcinoma of the breast. Similar neopl...

Dietary Isoflavones and Breast Cancer Risk.

Breast cancer is the deadliest neoplasm in women globally, resulting in a significant health burden. In many cases, breast cancer becomes resistant to chemotherapy, radiation, and hormonal therapies. ...

Evolution of oral neoplasm in an andalusian population (Spain).

Head and neck cancer are one of the most common neoplasm pathologies in humans. The aim of this study was to analyze the type, characteristics, treatment and evolution of oral neoplasm or precancerous...

Medical and Biotech [MESH] Definitions

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

Abnormal growths of tissue that follow a previous neoplasm but are not metastases of the latter. The second neoplasm may have the same or different histological type and can occur in the same or different organs as the previous neoplasm but in all cases arises from an independent oncogenic event. The development of the second neoplasm may or may not be related to the treatment for the previous neoplasm since genetic risk or predisposing factors may actually be the cause.

A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

More From BioPortfolio on "An Observational Study to Assess Response to Tamoxifen"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial