EARLY BREAST CANCER MedDRA version: 23.0 Level: PT Classification code 10065430 Term: HER2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Roche Farma S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed Informed Consent Form 2.Age = 18 years at time of signing Informed Consent Form 3.Ability to comply with the study protocol, in the investigator’s judgment 4.Eastern Cooperative Oncology Group (ECOG) Performance Status = 1 5.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. 6.Completed neoadjuvant treatment with pertuzumab and trastuzumab in combination with chemotherapy according to routine clinical practice, and have undergone surgery. 7.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 8.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. 9.Hormone receptor positive or negative for the primary tumor. 10.Baseline LVEF = 55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) 11.For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent (refrain from heterosexual intercourse) 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. 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 non-hormonal 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. 12.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 meth
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer 2. Any amount of residual disease in both breast and residual nodes, other than ypT0/is ypN0, will not be allowed to enter the study 3. Neoadjuvant treatment with trastuzumab alone 4. Already started systemic treatment for their breast cancer in the adjuvant setting 5. Need for chemotherapy during the adjuvant setting 6. 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 7. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years. 8. 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 9. Patients with bilateral breast cancer 10. Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes 11. Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy 12. 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 13. Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy 14. Treatment with any investigational drug within 28 days prior to randomization 15. 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) 16. 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 17. Inadequate bone marrow function, defined as: - Absolute neutrophil count 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 1.5 x ULN 20. Current severe, uncontrolled systemic d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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. - Quantify patient time savings for PH FDC SC vs Perjeta IV + Herceptin IV and Perjeta IV + Herceptin SC.;Secondary Objective: •Quantify total patient time spent in hospital for the different administration routes. •Quantify resource utilization reduction in terms of consumables related to the different administration routes. •To describe the safety and tolerability of PH FDC SC, P IV + H IV and P IV + H SC over the entire adjuvant treatment period.;Primary end point(s): - Average HCP time per patient per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes, time disaggregated per pre-specified task as well as per HCP (oncologist, nurse, pharmacist and other). - Average patient time per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes: patient chair time (measured as time between sitting and rising from infusion chair) and treatment room time (measured as time between entrance and exit from the treatment room).;Timepoint(s) of evaluation of this end point: At each site visit and for the entire duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Average patient hospital time per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes measured as time between first entry and last exit from the hospital. - Average quantity for each consumable used per patient visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, per pre-specified task for the different administration route processes. Milligrams wasted from partly-used vials per patient visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting - Incidence, nature and severity of all AEs, = Grade 3 AEs, serious adverse events (SAEs) and cardiac AEs (including left ventricular ejection fraction [LVEF] events). Incidence of premature withdrawal from study treatment. Targeted vital signs and physical findings. Targeted clinical laboratory test results.;Timepoint(s) of evaluation of this end point: At each site visit and for the entire duration of the study | — |
Countries
Spain
Contacts
Public ContactHead of Spain
Roche Farma S.A.
Outcome results
None listed