Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Chronic Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Antioxidants

Mitoquinone

Placebo

Allan Kluser Sales, PhD

Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.

Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:

1. increased mitochondrial oxidative stress;
2. the increase in cardiac markers (B-type natriuretic peptide and troponin I);
3. changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
4. endothelium-dependent dysfunction of peripheral vascular beds;
5. the increase in endothelial microvesicles;
6. the increase in material stiffness;
7. the elevation of central blood pressure.

Clinical, randomized, double-blind, placebo-controlled trial.

The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients

The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial

Cardiac function changes (Strain and Simpson's monoplanar)

Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);

changes in the endothelium-dependent function of peripheral vascular beds

Alterations on the central blood pressure

InCor Heart Institute

Instituto do Cancer do Estado de São Paulo

D'Or Institute for Research and Education

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Sarcoma

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Pharmaceutical Solutions

Anti-Infective Agents

Trabectedin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Classic Doxorubicin (Adriamycin - Doxorubicin hydrochloride) Presentation: Solution with 10, 20, or 50 mg Doxorubicin Hydrochloride. Excipients: hydrochloric acid and sodium chloride 0.9%, q.s. 25 ml.

Pharmaceutical form: concentrate for solution for infusion. Route of administration: Intravenous

Trabectedin Presentation: vials with trabectedin 1 mg and sucrose 400 mg. Pharmaceutical form: A white or whitish lyophilized powder as concentrate for solution for injection.

Route of administration: for intravenous use after reconstitution and further dilution.

Classic Doxorubicin (Adriamycin - Doxorubicin hydrochloride) Presentation: Solution with 10, 20, or 50 mg Doxorubicin Hydrochloride. Excipients: hydrochloric acid and sodium chloride 0.9%, q.s. 25 ml.

Pharmaceutical form: concentrate for solution for infusion. Route of administration: Intravenous

A maximum of 6 cycles every 3 weeks of doxorubicin monotherapy 75 mg/square meter will be given in the absence of progression or not acceptable toxicity.

A maximum of 6 cycles every 3 weeks of the combination (Trabectedin 1,1 mg/square meter + doxorubicin 60 mg/square meter) will be given in the absence of progression or not acceptable toxicity.

Javier Martin Broto, PhM

Andres Poveda, Ph.M.

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy.

This proposal arises from the need to bring to the first line of treatment of advanced STS agents that have shown activity in second line. The goal is to improve available standard treatments. Tumors in patients not previously exposed to chemotherapy have not been selected in their biological behavior and they are the best scenario to test antitumor activity of a new anticancer drug.

The combination of drugs with different mechanisms of action may be a clear advantage to obtain better results and potential synergy. On the other hand, the toxicity profiles of both study drugs are different and worsening or summative of adverse effects is not expected.

The purpose of this study is to determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS).

Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

Randomized, Open, Multicenter, Prospective, Phase II Clinical Trial of Doxorubicin vs. Trabectedin Plus Doxorubicin in the First Line Treatment of Patients With Advanced Non Operable and/or Metastatic Soft Tissue Sarcomas

To determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS). To this end, progression free survival will be compared between both groups of treatment.

To determine activity by means of RECIST objective responses in both study arms, trabectedin/doxorubicin combination and the control arm.

To determine the tumor control (response rates plus stabilizations) in both arms of treatment.

To determine activity by tissue changes applying the Choi criteria to Soft Tissue Sarcomas (STS)(see radiological review sub study).

To determine toxicity of trabectedin/doxorubicin combination and the control arm.

To determine protein and mRNA expression of genes possibly involved in a potential profile of more favorable response or resistance to study drugs and to analyze the prognostic impact of them on predefined efficacy parameters.

To evaluate genomic instability, as well as protein expression that could influence response/resistance to the study drugs and make a correlation with efficacy endpoints.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients	NCT05146843	Breast Neoplasm...	Mitoquinone Placebo	18 Years - 75 Years	D'Or Institute for Research and Education
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients	NCT05146843	Breast Neoplasm...	Mitoquinone Placebo	18 Years - 75 Years	D'Or Institute for Research and Education
Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS	NCT01104298	Sarcoma	Doxorubicin Trabectedin	18 Years - 70 Years	Grupo Espanol de Investigacion en Sarcomas

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