Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

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Bone Density Conservation Agents

Trastuzumab

Tamoxifen

Aromatase Inhibitors

Pertuzumab

Inavolisib

Phosphoinositide-3 Kinase Inhibitors

Enzyme Inhibitors

Inavolisib for 6 cycles (18 weeks) 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)

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)

daily application of 9 mg (may be decreased to 6 mg and to 3 mg)

fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase s.c. (PH-FDC SC) q3w beginning on day 1 of cycle 1 for 6 cycles (18 weeks)

PHESGO

Endocrine therapy per physician´s choice with either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men

Endocrine therapy

Konstantin Reißmüller

Mattea Reinisch, MD

Sherko Kümmel, MD, Prof.

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

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 (6cycles) or without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men.

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.

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

A Randomized, Open-label, Phase II Trial Comparing Neoadjuvant Endocrine Therapy in Combination With Trastuzumab, Pertuzumab +/- the PI3K Inhibitor Inavolisib in Patients With HER2-positive, HR-positive, PIK3CA Mutant Early Breast Cancer-GeparPiPPa

Pathological complete response (ypT0/is ypN0) is defined as no microscopic evidence of residual invasive tumor cells in all resected specimens of the breast and axilla.

ypT0 ypN0 is defined as no microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla; ypT0 ypN0/+ is defined as no microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast; ypT0/Tis ypN0/+ is defined as no microscopic evidence of residual invasive viable tumor cells in all resected specimens of the breast

Clinical (c) and imaging (i) response will be assessed every 2nd cycle and before surgery by physical examination and imaging tests. Sonography is the preferred examination.

The response categories of the breast are:

* Complete response (CR): complete disappearance of all tumor signs in the breast
* Partial response (PR): reduction in the product of the two largest perpendicular diameters of the primary tumor size by 50% or more
* Stable disease (NC): no significant change in tumor size during treatment which means an estimated reduction of the tumor area by less than 50%, or an estimated increase in the size of the tumor area lesions of less than 25%
* Progressive disease (PD): development of new, previously undetected lesions, or an estimated increase in the size of pre-existing lesions by 25% or more after at least two cycles of therapy

In case of ycT0 and no tumor residuals in the biopsy, it is recommended to undergo surgery. 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.

Breast conservation is defined as tumorectomy, segmentectomy or quadrantectomy as a most radical surgery.

Tolerability and safety analyses include assessment of patients whose treatment had to be dose reduced, delayed or permanently stopped. The reason for treatment discontinuation includes aspects of efficacy (e.g. discontinuation due to tumor progression), safety (e.g. discontinuation due to haematological and non-haematological adverse events) and compliance (e.g. discontinuation due to withdrawal of consent). Safety by toxicity grades are defined by the NCI-CTCAE version 5.0

Descriptive statistics for the 2 treatment arms will be given on the number of patients whose treatment had to be dose reduced, delayed or permanently stopped. Reasons for premature discontinuation will be categorized according to the main reason and will be presented in frequency tables. Safety by toxicity grades are defined by the NCI-CTCAE version 5.0, laboratory parameters will be converted in CTC-grades and reported together with other adverse events.

Survival endpoints are defined as the time period between randomization and first event and will be analyzed after the end of the study by referring to data from GBG´s registries

Spots Global Cancer Trial Database for geparpippa

Every month we try and update this database with for geparpippa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for geparpippa

Every month we try and update this database with for geparpippa cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for geparpippa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.