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 [5097 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 [14419 Associated PubMed Articles listed on BioPortfolio]

Investigating the Antiangiogenic, Anti-drug Resistance and Apoptotic Effects of Soy Isoflavone Extract Alone or in Combination with Docetaxel on Murine 4T1 Breast Tumor Model.

One major concern in the treatment of cancer patients during chemotherapy is drug resistance. Here we investigated the effects of soy isoflavone extracts alone or in combination with Docetaxel on the ...

Comparison of adverse events following injection of original or generic docetaxel for the treatment of breast cancer.

The approval of injectable generic drugs does not require bioequivalence testing. However, although generic products contain the same level of the active compound, the levels and types of additives pr...

Changes in volume and incidence of lymphedema during and after treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC) in patients with breast cancer.

The purposes of this study were to investigate the incidence of lymphedema in patients with breast cancer during and after adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC), t...

A randomised phase II trial of docetaxel versus docetaxel plus carboplatin in patients with castration-resistant prostate cancer who have progressed after response to prior docetaxel chemotherapy: The RECARDO trial.

Docetaxel is standard first-line chemotherapy for patients with metastatic castration-resistant prostate carcinoma (mCRPC). Docetaxel re-challenge has never been tested in a prospective randomised con...

Effect of docetaxel duration on clinical outcomes: exploratory analysis of CLEOPATRA, a phase III randomized controlled trial.

Combination pertuzumab, trastuzumab, and docetaxel (D) is considered standard first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This pos...

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