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Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

23:07 EDT 25th July 2014 | BioPortfolio

Summary

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Breast Cancer

Intervention

Neratinib, Lapatinib, Capecitabine

Location

Pfizer Investigational Site
Tucson
Arizona
United States
85704-7891

Status

Active, not recruiting

Source

Pfizer

Results (where available)

View Results

Links

Clinical Trials [3425 Associated Clinical Trials listed on BioPortfolio]

Study Evaluating the Combination of Neratinib and Capecitabine in Solid Tumors and Breast Cancer

This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in eac...

A Study of Neratinib (HKI-272) + Capecitabine in Japanese With Solid Tumor

This is an open-label, phase 1 study of ascending single cohort of neratinib (HKI-272) combination with capecitabine.

An Open-Label Study of Trastuzumab-MCC-DM1 (T-DM1) vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer

This is a Phase III, randomized, multicenter, international, two-arm, open-label clinical trial designed to compare the safety and efficacy of T-DM1 with that of capecitabine + lapatinib f...

APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)

This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urin...

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

PubMed Articles [17543 Associated PubMed Articles listed on BioPortfolio]

Lapatinib plus Capecitabine for HER2-Positive Advanced-Stage Breast Cancer in Elderly Women: Review of the Anatolian Society of Medical Oncology (ASMO) Experience.

The efficacy and safety of the lapatinib and capecitabine combination remain elusive in elderly patients with metastatic breast cancer (MBC), who progress after trastuzumab-based therapy.

A phase II, randomized, multicenter study evaluating the combination of lapatinib and vinorelbine in women with ErbB2 overexpressing metastatic breast cancer.

Lapatinib is approved in combination with capecitabine for treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who have progressed on pri...

Lapatinib in patients with metastatic breast cancer following initial treatment with trastuzumab: an economic analysis from the Brazilian public health care perspective.

To evaluate, from the perspective of the Brazilian public health care system, the cost-effectiveness of lapatinib plus capecitabine (LAP/CAP) versus capecitabine alone (CAP) or trastuzumab plus capeci...

Lapatinib: new opportunities for management of breast cancer.

Approximately 20% of new diagnosed breast cancers overexpress the human epidermal growth factor receptor 2 (EGFR2), also known as erythroblastic leukemia viral oncogene homolog 2 (ERBB2) protein, as a...

Lapatinib.

The human epidermal growth factor receptor (HER) family of receptor tyrosine kinases plays an important role in the biology of many cancers. In breast and gastric cancer, and maybe also additional tum...

Medical and Biotech [MESH] Definitions

An antineoplastic agent that is a derivative of progesterone and used to treat advanced breast cancer.

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.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

An aromatase inhibitor that produces a state of "medical" adrenalectomy by blocking the production of adrenal steroids. It also blocks the conversion of androgens to estrogens. Aminoglutethimide has been used in the treatment of advanced breast and prostate cancer. It was formerly used for its weak anticonvulsant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p454)

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

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