Clinical Trials List
Protocol NumberWO40324
NCT Number(ClinicalTrials.gov Identfier)NCT03493854
Completed
2018-07-01 - 2023-06-02
Phase III
Terminated3
ICD-10C50
Malignant neoplasm of breast
ICD-9174.9
Malignant neoplasm of female breast, unspecified
A PHASE III, RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER
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Trial Applicant
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Sponsor
ROCHE PRODUCTS LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/21
Investigators and Locations
Co-Principal Investigator
- Liang-Chih Liu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
- Yao-Chung Wu Division of General Surgery
- Chen-Teng Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 金光亮 Division of General Surgery
- Yi-Fang Tsai Division of General Surgery
- 邱仁輝 Division of General Surgery
- 林燕淑 Division of General Surgery
- Ta-Chung Chao Division of Hematology & Oncology
- Chun-Yu Liu Division of Hematology & Oncology
- 賴亦貞 Division of General Surgery
The Actual Total Number of Participants Enrolled
8 Completed
Audit
None
Co-Principal Investigator
Audit
None
Principal Investigator
Shin-Cheh Chen
Linkou Chang Gung Medical Foundation
Taiwan National PI
陳訓徹
Co-Principal Investigator
- Chi-Chang Yu Division of General Surgery
- Wen-Ling Kuo Division of General Surgery
- 沈士哲 Division of General Surgery
- 周旭桓 Division of General Surgery
- Wen-Chi Shen Division of Hematology & Oncology
- 翁世樺 Division of Others
- Yung-Chang Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
4 Completed
Audit
None
Condition/Disease
Early Breast Cancer
Objectives
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.
Test Drug
PHESGO
Active Ingredient
Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous
Dosage Form
Subcutaneous injection
Dosage
pertuzumab 1200mg + Trastuzumab 600mg/15ml
Endpoints
Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8) The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by >20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement. Pre-dose on Cycle 8, Day 1 (up to 21 weeks)
Inclution Criteria
Ability to comply with the study protocol, in the investigator's judgment
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Female and male patients with Stage II - IIIC (T2-T4 plus any N, or any T plus N1-N3, M0), locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
Primary tumor >2 cm in diameter, or node-positive disease (clinically or on imaging, and node positivity confirmed with cytology and/or histopathology)
HER2-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material.
Hormone receptor status of the primary tumor, centrally confirmed
Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy
Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research
Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent or use one highly effective non-hormonal contraceptive method with a failure rate of <1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy, and agreement to refrain from donating eggs during this same period
For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of HER2-targeted therapy to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
A negative serum pregnancy test must be available prior to randomization for WOCBP, unless they have undergone surgical sterilization
No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Female and male patients with Stage II - IIIC (T2-T4 plus any N, or any T plus N1-N3, M0), locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
Primary tumor >2 cm in diameter, or node-positive disease (clinically or on imaging, and node positivity confirmed with cytology and/or histopathology)
HER2-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material.
Hormone receptor status of the primary tumor, centrally confirmed
Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy
Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research
Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent or use one highly effective non-hormonal contraceptive method with a failure rate of <1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy, and agreement to refrain from donating eggs during this same period
For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of HER2-targeted therapy to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
A negative serum pregnancy test must be available prior to randomization for WOCBP, unless they have undergone surgical sterilization
No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
Exclusion Criteria
Stage IV (metastatic) breast cancer
Patients with a history of invasive breast cancer
Patients with a 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
Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
Patients with high-risk for breast cancer who have received chemo-preventative drugs in the past are not allowed to enter the study
Patients with multicentric breast cancer, unless all tumors are HER2-positive
Patients with bilateral breast cancer
Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
Axillary lymph node dissection prior to initiation of neoadjuvant therapy
Sentinel lymph node biopsy prior to neoadjuvant therapy
Treatment with any investigational drug within 28 days prior to randomization
Serious cardiac illness or medical conditions
Inadequate bone marrow function, renal function or impaired liver function
Current severe, uncontrolled systemic disease that may interfere with planned treatment
Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient'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
Concurrent, serious, uncontrolled infections, or known infection with HIV
Known hypersensitivity to study drugs, excipients, and/or murine proteins
Current chronic daily treatment with corticosteroids
History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
Patients with a history of invasive breast cancer
Patients with a 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
Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
Patients with high-risk for breast cancer who have received chemo-preventative drugs in the past are not allowed to enter the study
Patients with multicentric breast cancer, unless all tumors are HER2-positive
Patients with bilateral breast cancer
Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
Axillary lymph node dissection prior to initiation of neoadjuvant therapy
Sentinel lymph node biopsy prior to neoadjuvant therapy
Treatment with any investigational drug within 28 days prior to randomization
Serious cardiac illness or medical conditions
Inadequate bone marrow function, renal function or impaired liver function
Current severe, uncontrolled systemic disease that may interfere with planned treatment
Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient'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
Concurrent, serious, uncontrolled infections, or known infection with HIV
Known hypersensitivity to study drugs, excipients, and/or murine proteins
Current chronic daily treatment with corticosteroids
History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
The Estimated Number of Participants
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Taiwan
18 participants
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Global
500 participants
