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Spots Global Cancer Trial Database for Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

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Trial Identification

Brief Title: Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

Official Title: An Open-Label, Phase II, Study to Evaluate Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Receiving Treatment With Trastuzumab in Combination With Lapatinib or Chemotherapy (EGF117165)

Study ID: NCT02213042

Study Description

Brief Summary: This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study was a post-approval commitment with regulatory authorities. It was designed to evaluate whether treatment with Dual blockade promoted changes to biomarkers associated with immunomodulation.

Detailed Description: This study was designed to address the post-authorization measures as agreed with the Committee for Medicinal Products for Human Use (CHMP). Recruitment of subjects into this study was challenging, and following agreement with the European Medicines Agency (EMA) enrollment into this study was halted after the enrollment of 42 of the 225 planned subjects. The primary endpoint of the study evaluated changes in expression of biomarkers associated with immunomodulation between a pre-treatment biopsy and the disease progression biopsy. Secondary efficacy endpoints included overall response rate, clinical benefit rate and progression-free survival (PFS), as well as safety/tolerability. All subjects received study treatment until disease progression, death, unacceptable toxicity, or subject withdrawal. In case of disease progression during the treatment period, the subject was followed-up for 30 days for safety evaluation. In case of study treatment discontinuation for any reasons other than disease progression, the subject was followed-up for safety and efficacy assessments until disease progression, new anticancer therapy, death, withdrawal of consent or end of study, whichever came first. This study supported a better understanding of the rapidly accumulating evidence for the importance of the immune microenvironment in HER2-positive breast cancer and the observed immunomodulation in the neoadjuvant setting could be confirmed in the advanced setting and supported the putative mechanism of action of HER2 dual blockade and its potential function on the tumor microenvironment. No formal comparisons between treatment arms were undertaken.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Novartis Investigative Site, Mobile, Alabama, United States

Novartis Investigative Site, Boston, Massachusetts, United States

Novartis Investigative Site, Houston, Texas, United States

Novartis Investigative Site, Berazategui, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Viedma, Río Negro, Argentina

Novartis Investigative Site, Rosario, Santa Fe, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Cordoba, , Argentina

Novartis Investigative Site, La Rioja, , Argentina

Novartis Investigative Site, San Miguel de Tucuman, , Argentina

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Salvador, Bahía, Brazil

Novartis Investigative Site, Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Itajai, Santa Catarina, Brazil

Novartis Investigative Site, Barretos, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Jose do Rio Preto, , Brazil

Novartis Investigative Site, Pok Fu Lam, , Hong Kong

Novartis Investigative Site, Pokfulam, , Hong Kong

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Mexico, , Mexico

Novartis Investigative Site, Arequipa, , Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Cebu, , Philippines

Novartis Investigative Site, Manila, , Philippines

Novartis Investigative Site, Kazan, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Ryazan, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, Volzhskiy, , Russian Federation

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Donostia, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Malaga, , Spain

Novartis Investigative Site, Sevilla, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Chiangmai, , Thailand

Novartis Investigative Site, Phitsanulok, , Thailand

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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