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Metastatic Breast Cancer clinical trials

View clinical trials related to Metastatic Breast Cancer.

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NCT ID: NCT00567190 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

CLEOPATRA
Start date: February 12, 2008
Phase: Phase 3
Study type: Interventional

This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.

NCT ID: NCT00555919 Completed - Clinical trials for Metastatic Breast Cancer

ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer

Start date: March 2008
Phase: Phase 2
Study type: Interventional

Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed since their previous cancer treatment and that cannot be removed completely by surgery are eligible to be treated within this trial.Treatment with a new drug called Progesterone Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be expressed on breast cancer tumour cells. Therefore only patients with this progesterone receptor on their tumour cells can be included in this study.Progesterone receptor antagonists (including onapristone) have already shown efficacy in postmenopausal women with advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg) before initiating pivotal phase III trials.

NCT ID: NCT00534417 Completed - Clinical trials for Metastatic Breast Cancer

Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.

NCT ID: NCT00532623 Completed - Clinical trials for Metastatic Breast Cancer

Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer

Start date: May 2004
Phase: Phase 2
Study type: Interventional

To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer.

NCT ID: NCT00532272 Completed - Clinical trials for Metastatic Breast Cancer

Goserelin/Letrozole in Premenopausal Patients vs Letrozole Alone in Postmenopausal Patients With MBC

Start date: October 2005
Phase: Phase 2
Study type: Interventional

Primary objective is to evaluate the response rates and clinical benefits of letrozole + goserelin in premenopausal patients versus letrozole alone in postmenopausal patients with metastatic breast cancer as first line hormonal therapy

NCT ID: NCT00531271 Terminated - Clinical trials for Metastatic Breast Cancer

ABI-008 Trial in Patients With Metastatic Breast Cancer

Start date: November 1, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every 3 weeks; to characterize the toxicities of ABI-008; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule to patients with metastatic breast cancer.

NCT ID: NCT00525096 Completed - Clinical trials for Metastatic Breast Cancer

Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

Start date: July 2003
Phase: Phase 3
Study type: Interventional

To discover if the adding of a coxib increases the efficacy of the Aromasine.

NCT ID: NCT00524849 Completed - Clinical trials for Metastatic Breast Cancer

Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis

Start date: November 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be randomized into two groups.

NCT ID: NCT00524810 Completed - Clinical trials for Metastatic Breast Cancer

Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Start date: February 2004
Phase: Phase 2
Study type: Interventional

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

NCT ID: NCT00522457 Terminated - Clinical trials for Metastatic Breast Cancer

Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy

Start date: January 2008
Phase: Phase 2
Study type: Interventional

This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progressing after trastuzumab treatment. Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.