{"id":4940,"date":"2024-01-26T11:55:11","date_gmt":"2024-01-26T10:55:11","guid":{"rendered":"https:\/\/studienportal-brustkrebs.de\/geparpippa-gbg-105\/"},"modified":"2025-07-30T11:48:50","modified_gmt":"2025-07-30T09:48:50","slug":"geparpippa-gbg-105","status":"publish","type":"post","link":"https:\/\/studienportal-brustkrebs.de\/en\/geparpippa-gbg-105\/","title":{"rendered":"GeparPiPPa \/ GBG-105"},"content":{"rendered":"\t\t
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GeparPiPPa \/ GBG-105<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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THERAPY STUDY TO EVALUATE THE POTENTIAL ADDITIONAL EFFICACY AND SAFETY OF INAVOLISIB<\/em> IN THE PRE-OPERATIVE TREATMENT OF PATIENTS WITH HER2-POSITIVE, HR-POSITIVE, PIK3CA-MUTATED EARLY BREAST CANCER.<\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"GeparPippa-GBG-105-Brustkrebsstudie\"\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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GeparPiPPa is a randomized (chance determines the treatment for each patient), non-blinded (doctor and patient know which medications are being used) Phase II study comparing pre-operative anti-hormone therapy in combination with the immunotherapeutics Trastuzumab<\/em>, Pertuzumab<\/em> with and without the PIK3 inhibitor Inavolisib<\/em> in patients with HER2-positive, HR-positive, PIK3CA-mutated early (non-metastatic) breast cancer.<\/p>\n

What is being investigated in this study?<\/strong><\/p>\n

The investigation of receptor status is a central aspect in the diagnosis of breast cancer. This status provides information about the presence of certain molecules in tumor cells or on their surface, which can serve as potential targets for drug treatments. One of these molecule groups is known as \u201cHER2\u201d. \u201cHER2\u201d stands for \u201cHuman Epidermal Growth Factor Receptor 2\u201d. HER2 is a receptor on the cell surface of tumors that stimulates cell growth when activated. 20-30% of all patients with a high number of HER2 receptors (HER2 positive) on the tumor have a mutation in the PIK3CA gene. This gene is essential for the production of the enzyme PI3K, which is important for cell division, among other things. Tumors with PIK3CA mutations may have a poorer response to chemotherapy and anti-HER2 therapy. This is particularly true for breast cancer with positive hormone receptor expression (HR+). Inavolisib<\/em> is an oral PI3KA inhibitor that is comparable to other drugs in the same class but is expected to have a better efficacy and tolerability profile. <\/p>\n

What is the goal of the study?<\/strong><\/p>\n

The primary goal of the study is to compare the efficacy of therapy with Inavolisib<\/em> along with concurrent endocrine therapy (anti-hormone therapy), Pertuzumab<\/em>, and Trastuzumab<\/em> versus endocrine therapy with Pertuzumab<\/em> and Trastuzumab<\/em> alone in patients with HER2-positive, HR-positive, PIK3CA-mutated early breast cancer. Additionally, the safety and tolerability of the treatment, as well as patient adherence, will be investigated. <\/p>\n

How is the study conducted?<\/strong><\/p>\n

Breast cancer patients with a PIK3CA mutation will be randomly assigned 1:1 to one of two treatment arms and will receive:<\/p>\n

Arm A
<\/u>Anti-hormone therapy before surgery, in combination with immunotherapy (dual anti-HER2 blockade, consisting of Pertuzumab<\/em> and Trastuzumab<\/em> as an injection administered subcutaneously for 6 cycles (18 weeks)), combined with Inavolisib<\/em> in tablet form for 6 cycles (18 weeks)<\/p>\n

Arm B
<\/u>Treatment regimen identical to Arm A, but without Inavolisib<\/em><\/p>\n

Anti-hormone therapy consists of either Tamoxifen<\/em> or an aromatase inhibitor (medication to inhibit estrogen production), possibly combined with a GnRH analog (medication to prevent ovulation) for premenopausal women and for all men. In both study arms, treatment will continue until surgery\/biopsy is performed, or progressive, unacceptable side effects occur, or consent to the study is withdrawn. <\/p>\n

Are there risks?<\/strong><\/p>\n

You will be informed about potential risks and side effects associated with participation during an informational discussion.<\/p>\n

Participation Requirements<\/strong><\/p>\n

Men and women aged 18 and older can participate in this study, with:<\/p>\n