Advertisement

Topics

A Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel in Patients With Advanced Breast Cancer

2014-08-27 03:54:04 | BioPortfolio

Summary

This was a randomized, active control, parallel-group, open-label, multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant or adjuvant setting, and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL/CAELYX to docetaxel therapy.

Description

The safety and effectiveness of DOXIL in combination with docetaxel will be compared to treatment with docetaxel alone (monotherapy). The primary objective of this study was to evaluate whether the time to progression for the DOXIL/CAELYX and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy. Secondary objectives were to compare the treatment groups for overall survival, response rate (complete plus partial responses), the effect of treatment on patient-reported outcomes using the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument, and the safety profile. Patients randomly assigned in a 1:1 allocation to treatment will receive either docetaxel (75 mg/m2 on Day 1 of every 21-day cycle) or DOXIL/CAELYX (30 mg/m2) followed by docetaxel (60 mg/m2) on Day 1 of every 21-day cycle.

Study Design

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

Conditions

Cancer of Breast

Intervention

Docetaxel, DOXIL in combination with Docataxel

Status

Completed

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:04-0400

Clinical Trials [5468 Associated Clinical Trials listed on BioPortfolio]

Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)

This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine th...

Doxorubicin HCL Liposome Injection (DOXIL) in Combination With Abraxane in Patients With Metastatic Breast Cancer

Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) [Phase I and II]

Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients wi...

Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer

Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. T...

Therapy for Locally Advanced Breast Cancer Using Doxil, Paclitaxel, and Cyclophosphamide With Avastin

This study will evaluate the rate of response to the sequential therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with locally advanced invasive (T2,T...

PubMed Articles [14179 Associated PubMed Articles listed on BioPortfolio]

Association of Allelic Interaction of Single Nucleotide Polymorphisms of Influx and Efflux Transporters Genes With Nonhematologic Adverse Events of Docetaxel in Breast Cancer Patients.

Nonhematologic adverse events (AEs) of docetaxel constitute an extra burden in the treatment of cancer patients and necessitate either a dose reduction or an outright switch of docetaxel for other reg...

Effectiveness and tolerability of neoadjuvant pertuzumab-containing regimens for HER2-positive localized breast cancer.

Based on improvement in pathologic complete response (pCR) in the NeoSphere and TRYPHAENA studies, the FDA approved neoadjuvant pertuzumab for HER2+ localized breast cancer. These studies demonstrat...

Therapeutic efficacy of lipid emulsions of docetaxel-linoleic acid conjugate in breast cancer.

Docetaxel (DTX) solution is among the most widely-used parenteral formulations used in advanced breast cancer therapy. However, severe side effects have been observed due to the use of ethanol and pol...

Pharmacokinetic properties of wogonin and its herb-drug interactions with docetaxel in rats with mammary tumors.

Docetaxel, frequently used for the treatment of breast cancer, is mainly metabolized via hepatic cytochrome P450 (CYP) 3A in humans and is also a substrate of P-glycoprotein (P-gp). Wogonin has been s...

Anthracycline Use for Early Stage Breast Cancer in the Modern Era: a Review.

Anthracycline-based regimens have been an important treatment component for patients with breast cancer. As demonstrated in the last Early Breast Cancer Trialists' Collaborative Group (EBCTCG) meta-an...

Medical and Biotech [MESH] Definitions

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.

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)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

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.

More From BioPortfolio on "A Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel in Patients With Advanced Breast Cancer"

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'...

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...


Searches Linking to this Trial