Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Bevacizumab

Albumin-Bound Paclitaxel

Imetelstat

Motesanib diphosphate

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.

Imetelstat sodium

Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle

Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle

Ted Shih, PharmD

Kathy Miller, MD

The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.

Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.

Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

A Randomized Phase II Study Of Imetelstat (GRN163L) In Combination With Paclitaxel (With Or Without Bevacizumab) in Patients With Locally Recurrent Or Metastatic Breast Cancer

Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.

Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.

Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.

Geron Corporation

Triple Negative Breast Neoplasms

Vinorelbine

Taxane

The eribulin mesylate dose will be 1.4 mg/m2 administered as an intravenous bolus over 2 to 5 minutes on Days 1 and 8 of each 21-day cycle.

The vinorelbine dose will be 25 mg/m2 administered as an intravenous bolus on Days 1, 8, and 15 of each 21-day treatment cycle.

E7389 (Eribulin Mesylate)

Vinorelbine injection

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.

Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

Eisai Co., Ltd.

Docetaxel

Nintedanib

200 mg x 2 per os daily from D2\*

\*No Nintedanib on days when docetaxel is administered

Dose can be increased to 100 mg/m² secondarily at cycle 2 on the initiative of the investigator

Docetaxel: increase of the dose

Jacques BONNETERRE, MD PhD

National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.

Patients will be stratified at randomization according to first-line chemotherapy / Second-line chemotherapy for metastatic or locally recurrent breast cancer

Treatment until progression or unacceptable toxicity Visits are planned every 3 weeks during treatment and every 3 months after end of treatment or patient's withdrawal

Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a First or Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer

time from the date of randomization to the date of death from any cause

questionnaire : EORTC QLQ C30 (Additional module BR23)

biological analysis of cells RT-qPCR analysis, including endothelial cells using a specific reference gene

biological analysis in patient's serum Dosage of VEGF-A, -C, FGF-1, -2, PDGF-AA, -AB, -BB in patient's serum

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer	NCT01256762	Locally Recurre...	Imetelstat sodi... Bevacizumab Paclitaxel	18 Years -	Geron Corporation
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer	NCT01256762	Locally Recurre...	Imetelstat sodi... Bevacizumab Paclitaxel	18 Years -	Geron Corporation
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes	NCT02225470	HER2-Negative B... Triple Negative... Breast Cancer Cancer of Breas... Breast Tumors	E7389 (Eribulin... Vinorelbine inj...	18 Years - 70 Years	Eisai Inc.
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes	NCT02225470	HER2-Negative B... Triple Negative... Breast Cancer Cancer of Breas... Breast Tumors	E7389 (Eribulin... Vinorelbine inj...	18 Years - 70 Years	Eisai Inc.
Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer	NCT01658462	Breast Cancer	Docetaxel Nintedanib Docetaxel: incr...	18 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for locally recurrent or metastatic breast cancer