A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer (ProHer)

  • STATUS
    Recruiting
  • End date
    Sep 25, 2025
  • participants needed
    330
  • sponsor
    Hoffmann-La Roche
Updated on 18 October 2022
paclitaxel
cyclophosphamide
growth factor
doxorubicin
carboplatin
pertuzumab
immunohistochemistry
epidermal growth factor receptor
HER2
EGFR
docetaxel
trastuzumab
erbb2
epidermal growth factor
her2/neu-positive breast cancer
taxane
mastectomy
breast-conserving surgery

Summary

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

Details
Condition Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer
Treatment Radiotherapy, Surgery, Trastuzumab Emtansine, Trastuzumab IV, Pertuzumab IV, Investigator's Choice of Chemotherapy, Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
Clinical Study IdentifierNCT05415215
SponsorHoffmann-La Roche
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Intact skin at planned site of subcutaneous (SC) injections
Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
Negative human immunodeficiency virus (HIV) test at screening
Negative hepatitis B surface antigen (HBsAg) test at screening
Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period and for 7 months after the final dose of the study treatment
For male participants: agreement to remain abstinent or use a condom, and agree to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment
Disease-specific Inclusion Criteria
Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer
Primary tumor >2 centimetres (cm) in diameter, or node-positive disease
HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018)
Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates (Allison et al. J Clin Oncol 2020)
Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes
Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines
Inclusion Criteria for Treatment with Adjuvant PH FDC SC
Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual
Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy

Exclusion Criteria

Stage IV (metastatic) breast cancer
History of concurrent or previously treated non-breast malignancies, except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years
Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Active, unresolved infections at screening requiring treatment
Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR)
Serious cardiac illness or medical conditions
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Inadequate bone marrow function
Impaired liver function
Renal function with creatinine clearance <50 mL/min using the Cockroft-Gault formula and serum creatinine >1.5x upper limit of normal (ULN)
Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
Current severe, uncontrolled systemic disease that may interfere with planned treatment
Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis
Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma
Current chronic daily treatment with corticosteroids
Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
Cancer-specific Exclusion Criteria for Neoadjuvant Phase
Participants who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for the treatment of cancer
Participants who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsi- or contralateral breast cancer
Participants with high-risk for breast cancer who have received chemopreventive drugs in the past
Participants with multicentric breast cancer, unless all tumors are HER2+
Participants with bilateral breast cancer
Participants who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy
Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy
Exclusion Criterion for Treatment with Adjuvant Trastuzumab Emtansine (Arm E)
Current Grade ≥3 peripheral neuropathy (according to the NCI CTCAE v5.0)
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