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TIME AND MOTION STUDY OF A SUBCUTANEOUS FIXED DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB FOR THE TREATMENT OF PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER (PHATIMA)
EU CTIS ID: 2023-509321-50-00
What this study is testing
Quantify HCP time savings for PH FDC SC vs Perjeta IV + Herceptin IV and Perjeta IV + Herceptin SC in the treatment of HER2-positive EBC patients; and quantify patient time savings for PH FDC SC vs Perjeta IV + Herceptin IV and Perjeta IV + Herceptin SC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed Informed Consent Form
- Baseline 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 (refrain from heterosexual intercourse) or use one highly effective nonhormonal contraceptive method with a failure rate of < 1% per year, or two effective nonhormonal 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. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of highly effective nonhormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom in combination with a spermicidal foam, gel, film, cream, or suppository, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, 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. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
- A negative serum pregnancy test must be available prior to randomization for WOCBP (premenopausal women and women < 12 months after the onset of menopause), unless they have undergone surgical sterilization (removal of ovaries and/or uterus)
- 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
You likely can't join if
- Stage IV (metastatic) breast cancer
- Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy. ● Patients with clinically negative axilla (by physical examination and radiographic imaging) may undergo a core or needle biopsy procedure prior to neoadjuvant systemic therapy if in keeping with local practice
- Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy
- Treatment with any investigational drug within 28 days prior to randomization
- Serious cardiac illness or medical conditions including, but not confined to, the following: ● History of NCI CTCAE (v5) Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II ● High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate ≥ 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block, such as second degree AV-block Type 2 [Mobitz 2] or third-degree AV-block) ● Serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality ● Angina pectoris requiring anti-anginal medication ● Clinically significant valvular heart disease ● Evidence of transmural infarction on ECG ● Evidence of myocardial infarction within 12 months prior to starting neoadjuvant treatment ● Poorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100 mmHg)
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe LVSD, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
See the full eligibility criteria
Who can join
- Signed Informed Consent Form
- Baseline 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 (refrain from heterosexual intercourse) or use one highly effective nonhormonal contraceptive method with a failure rate of < 1% per year, or two effective nonhormonal 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. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of highly effective nonhormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom in combination with a spermicidal foam, gel, film, cream, or suppository, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, 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. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
- A negative serum pregnancy test must be available prior to randomization for WOCBP (premenopausal women and women < 12 months after the onset of menopause), unless they have undergone surgical sterilization (removal of ovaries and/or uterus)
- 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
- Age ≥ 18 years at time of signing Informed Consent Form
- 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 locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed node positive invasive breast cancer with initial diagnosis TNM staging any T (except T0) plus N+ and M0
- Completed neoadjuvant treatment with pertuzumab and trastuzumab in combination with chemotherapy according to routine clinical practice, and have undergone surgery for their breast cancer. Note that study treatment cannot be initiated within < 2 weeks from surgery but must be initiated ≤ 8 weeks from surgery
- Confirmed tpCR (total pathologic complete response), defined as eradication of invasive disease in the breast and axilla (i.e., ypT0/is ypN0), according to local pathologist assessment
- HER2-positive breast cancer confirmed by a local laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material and defined as 3+ by IHC and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies
- Hormone receptor status of the primary tumour determined by local assessment. Hormone receptor status may be either positive (i.e. ER-positive and/or PgR positive) or negative (i.e. ER-negative and PgR-negative)
What rules you out
- Stage IV (metastatic) breast cancer
- Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy. ● Patients with clinically negative axilla (by physical examination and radiographic imaging) may undergo a core or needle biopsy procedure prior to neoadjuvant systemic therapy if in keeping with local practice
- Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy
- Treatment with any investigational drug within 28 days prior to randomization
- Serious cardiac illness or medical conditions including, but not confined to, the following: ● History of NCI CTCAE (v5) Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II ● High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate ≥ 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block, such as second degree AV-block Type 2 [Mobitz 2] or third-degree AV-block) ● Serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality ● Angina pectoris requiring anti-anginal medication ● Clinically significant valvular heart disease ● Evidence of transmural infarction on ECG ● Evidence of myocardial infarction within 12 months prior to starting neoadjuvant treatment ● Poorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100 mmHg)
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe LVSD, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
- Cumulative prior anthracycline exposure to > 360 mg/m2 of doxorubicin or its equivalent
- Inadequate bone marrow function, defined as: ● Absolute neutrophil count < 1.5 x 109/L ● Platelet count < 100 x 109/L ● Hemoglobin < 9 g/dL
- Impaired liver function, defined as: ● Serum (total) bilirubin > 1.25 x upper limit of normal (ULN). In case of Gilbert’s syndrome: a total bilirubin of 2 x ULN is permitted. ● Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.25 x ULN ● Albumin < 25 g/L
- Inadequate renal function with serum creatinine > 1.5 x ULN
- Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
- Any amount of residual disease in both breast and residual nodes, other than ypT0/is ypN0, will not be allowed to enter the study
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy ● Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
- 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 (i.e., hepatitis B or hepatitis C), 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 (dose > 10 mg methylprednisolone or equivalent excluding inhaled steroids)
- Neoadjuvant treatment with trastuzumab alone
- Already started systemic anti-HER2 treatment for their breast cancer in the adjuvant setting
- Need for chemotherapy during the adjuvant setting
- Current or prior history of active malignancy (other than current breast cancer) within the last five years. Appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin or 3) stage I uterine cancer within the last five years are allowed. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years
- Patients who have a past history of ductal carcinoma in situ (DCIS), infiltrative ductal carcinoma (IDC), lobular carcinoma in situ (LCIS) or infiltrative lobular carcinoma (ILC) if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
- Patients with bilateral breast cancer
- Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.