GeparPIPPa (GBG 105)

This is a multicenter, prospective, randomized, open-label, parallel-group, phase II study to evaluate the potential incremental efficacy and safety of inavolisib in the neoadjuvant treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer. 170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive: Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks) • with inavolisib (6 cycles) or • without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue. In both study arms, treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient. All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate. In case of ycT0 and no tumor residuals in the biopsy, it is recommended to undergo surgery; in case of tumor residuals in the biopsy further neoadjuvant treatment may be given (the patient will be considered no pCR for the study regardless of the response to the further neoadjuvant treatment). Pseudonymized histology and surgery reports will be collected. Further neoadjuvant or adjuvant treatment including chemotherapy, radiotherapy, endocrine therapy and HER2-therapy will be administered at the discretion of the investigator and according to standard of care. Information on those additional adjuvant treatments will be captured within a registry.

The study investigates the potential efficacy and safety of inavolisib in the neoadjuvant treatment of HER2-positive, HR-positive, PIK3CA-mutated breast cancer. 170 patients with confirmed inclusion criteria and PIK3CA-mutated breast cancer will receive neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of a ready-to-use fixed-dose combination of pertuzumab and trastuzumab as a subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks), randomized 1:1 with or without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men. To assess the pCR rate, all patients will undergo surgery or biopsy after completion of study therapy. In case of ypT0 and no residual tumor in the biopsy, surgery is recommended; if residual tumor in the biopsy is present, further neoadjuvant treatment may be performed.

{ "short_title": "GeparPIPPa (GBG 105)", "data_mode": "900", "data_mode_number": "000002351", "official_title": "Eine randomisierte, offene Phase-II-Studie zum Vergleich einer neoadjuvanten endokrinen Therapie in Kombination mit Trastuzumab, Pertuzumab +/- dem PI3K-Inhibitor Inavolisib bei Patienten mit HER2-positivem, HR-positivem, PIK3CA-mutiertem prim\u00c3\u00a4ren Brustkrebs - GeparPiPPa", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "first", "ctgov_number": null, "eudract_number": "2022-501152-28", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Dr. Theresa Link", "description_laie_de": "Die Studie untersucht die potenzielle Wirksamkeit und Sicherheit von Inavolisib bei der neoadjuvanten Behandlung von HER2-positivem, HR-positivem, PIK3CA-mutiertem Brustkrebs.\r\n\r\n170 Patientinnen mit best\u00e4tigten Einschlusskriterien und PIK3CA-mutiertem Brustkrebs erhalten eine neoadjuvante endokrine Therapie in Kombination mit einer dualen Anti-HER2-Blockade, bestehend aus einer gebrauchsfertigen Fix-Dosis-Kombination von Pertuzumab und Trastuzumab als subkutane (PH-FDC SC) Formulierung q3w f\u00fcr 6 Zyklen (18 Wochen), randomisiert im Verh\u00e4ltnis 1:1 mit oder ohne Inavolisib.\r\n\r\nDie endokrine Therapie besteht entweder aus Tamoxifen 20mg oder einem Aromatasehemmer +/- GnRH-Analogon f\u00fcr pr\u00e4menopausale Frauen und M\u00e4nner.\r\n\r\nZur Beurteilung der pCR-Rate unterziehen sich alle Patienten nach Abschluss der Studientherapie einer Operation oder Biopsie. Bei ypT0 und keinen Tumorresten in der Biopsie wird eine Operation empfohlen; bei Tumorresten in der Biopsie kann eine weitere neoadjuvante Behandlung erfolgen.", "description_laie_en": "The study investigates the potential efficacy and safety of inavolisib in the neoadjuvant treatment of HER2-positive, HR-positive, PIK3CA-mutated breast cancer.\r\n\r\n170 patients with confirmed inclusion criteria and PIK3CA-mutated breast cancer will receive neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of a ready-to-use fixed-dose combination of pertuzumab and trastuzumab as a subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks), randomized 1:1 with or without inavolisib.\r\n\r\nEndocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men.\r\n\r\nTo assess the pCR rate, all patients will undergo surgery or biopsy after completion of study therapy. In case of ypT0 and no residual tumor in the biopsy, surgery is recommended; if residual tumor in the biopsy is present, further neoadjuvant treatment may be performed.", "description_expert_de": "Dies ist eine multizentrische, prospektive, randomisierte, offene Parallelgruppenstudie der Phase II zur Bewertung der potenziellen inkrementellen Wirksamkeit und Sicherheit von \r\nInavolisib in der neoadjuvanten Behandlung von HER2-positivem, HR-positivem, PIK3CA-mutiertem Brustkrebs im Fr\u00fchstadium. \r\n170 Patienten mit best\u00e4tigten Eignungskriterien und PIK3CA-mutiertem Brustkrebs werden im Verh\u00e4ltnis 1:1 randomisiert und erhalten: Neoadjuvante endokrine Therapie in Kombination mit dualer Anti-HER2-Blockade bestehend aus einer gebrauchsfertigen Fixdosiskombination von Pertuzumab und Trastuzumab als subkutane (PH-FDC SC) Formulierung q3w f\u00fcr 6 Zyklen (18 Wochen) \u2022 mit Inavolisib (6 Zyklen) oder \u2022 ohne Inavolisib. Die endokrine Therapie besteht entweder aus Tamoxifen 20 mg oder einem Aromatasehemmer +/- GnRH-Analogon. In beiden Studienarmen wird die Behandlung bis zur Operation/Stanzbiopsie, Krankheitsprogression, inakzeptabler Toxizit\u00e4t oder dem Widerruf der Einwilligung des Patienten fortgesetzt. Alle Patienten werden nach Abschluss der Studientherapie einer Operation oder Biopsie unterzogen, um die pCR-Rate zu ermitteln. Im Falle von ycT0 und ohne Tumorreste in der Biopsie wird eine Operation empfohlen; im Falle von Tumorresten in der Biopsie kann eine weitere neoadjuvante Behandlung erfolgen (der Patient wird f\u00fcr die Studie als nicht pCR betrachtet, unabh\u00e4ngig von der Reaktion auf die weitere neoadjuvante Behandlung). Es werden pseudonymisierte Histologie- und Operationsberichte gesammelt. Weitere neoadjuvante oder adjuvante Behandlungen, einschlie\u00dflich Chemotherapie, Strahlentherapie, endokriner Therapie und HER2-Therapie, werden nach Ermessen des Pr\u00fcfers und gem\u00e4\u00df dem Behandlungsstandard verabreicht. Informationen zu diesen zus\u00e4tzlichen adjuvanten Behandlungen werden in einem Register erfasst.", "description_expert_en": "This is a multicenter, prospective, randomized, open-label, parallel-group, phase II study to evaluate the potential incremental efficacy and safety of \r\ninavolisib in the neoadjuvant treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer. \r\n170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive: Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks) \u2022 with inavolisib (6 cycles) or \u2022 without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue. In both study arms, treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient. All patients will undergo surgery or biopsy after completing study therapy to \r\nassess pCR rate. In case of ycT0 and no tumor residuals in the biopsy, it is recommended to undergo surgery; in case of tumor residuals in the biopsy \r\nfurther neoadjuvant treatment may be given (the patient will be considered no pCR for the study regardless of the response to the further neoadjuvant \r\ntreatment). Pseudonymized histology and surgery reports will be collected. Further neoadjuvant or adjuvant treatment including chemotherapy, radiotherapy, endocrine therapy and HER2-therapy will be administered at the discretion of the investigator and according to standard of care. Information on those additional adjuvant treatments will be captured within a registry.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 3, "sub_cat_id": 16 }

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