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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Novartis Investigative Site, Mobile, Alabama, United States
Novartis Investigative Site, Boston, Massachusetts, United States
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Novartis Investigative Site, Berazategui, Buenos Aires, Argentina
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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
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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
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Novartis Investigative Site, Cebu, , Philippines
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Novartis Investigative Site, Kazan, , Russian Federation
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Novartis Investigative Site, Volzhskiy, , Russian Federation
Novartis Investigative Site, Barcelona, , Spain
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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
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR