Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
Endometrial Serous Adenocarcinoma, Uterine Corpus Carcinosarcoma
About this trial
This is an interventional treatment trial for Endometrial Serous Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma
- Histologic confirmation of the original primary tumor is required. Submission of surgical pathology report (or endometrial biopsy pathology report in patients who never undergo hysterectomy) is required
- Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration
- Patients may have measurable disease, non-measurable disease, or no measurable disease. In patients with measurable disease, lesions will be defined and monitored by RECIST v 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium. Any amount of myoinvasion is acceptable for eligibility. Patients with non-invasive disease, endometrial intraepithelial carcinoma alone, or disease confined to a polyp will be excluded
Additionally, patients must have the following histologic types to be eligible:
- Serous adenocarcinoma (may include =< 10% non-serous histology)
- Carcinosarcoma with serous epithelial component (only the serous component needs to be HER2 positive; may include =< 10% non-serous histology)
- In cases where determination of serous is equivocal or challenging, aberrant p53 immunohistochemistry (IHC) (defined as overexpression of p53 compared to internal controls) will be sufficient for inclusion
All patients must have tumors that are HER2 positive as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 Breast Cancer guidelines (https://documents.cap.org/documents/algorithim-evaluation-her2.pdf. In general HER2 positivity is defined as any of the following:
- 3+ immunohistochemistry (IHC),
- 2+ IHC with positive in situ hybridization (ISH)
- Average HER2 copy number >= 6.0 signals/cell
- Average HER2 copy number >= 4.0 and < 6.0 signals/cell, with concurrent IHC 3+
- HER2/CEP17 ratio >= 4.0 signals/cell
- HER2/CEP 17 ratio >= 2.0 and < 4.0, with concurrent IHC 3+ IHC and ISH testing will be done locally, at each participating institution and interpreted by local pathologists. Alternatively, patients could be eligible if next generation sequencing (NGS) demonstrates HER2 (ERBB2) amplification. NGS testing can be performed through any designated labs as per the National Cancer Institute (NCI) MATCH/NCI Combo-MATCH trial (https://ecog-acrin.org/nci-match-eay131-designated-labs).
Pathology report showing results of institutional HER2 testing (or NGS testing results) must be submitted.
Sites must submit all results available (IHC, ISH, and NGS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Age >= 18
- Platelets >= 100,000/mcl (within 14 days prior to registration)
- Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration)
- Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) or estimated Glomerular filtration rate (eGFR) >= 50 mL/min using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR). (within 14 days prior to registration)
- Total serum bilirubin level =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled) (within 14 days prior to registration)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
Although the uterus will have been removed in the vast majority of patients, for patients of child-bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Patients will be considered of non-reproductive potential if they are either:
- Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR
- Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to registration
- Have a congenital or acquired condition that prevents childbearing
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. NOTE: Patients with prior anthracycline exposure are NOT eligible
- Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria:
Prior Therapy:
- Patients must NOT have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma
Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy
- NOTE: Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment. Planned use of vaginal brachytherapy must be declared at time of registration
- Patients may have received prior hormonal therapy for treatment of endometrial carcinoma. All hormonal therapy must be discontinued at least one week prior to registration
- Patients may not have a planned interval cytoreduction or hysterectomy, prior to documentation of progression, after study registration
- Patients may not have planned external beam radiotherapy, prior to documentation of progression, after study registration
Significant cardiovascular disease including:
- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications
- Myocardial infarction or unstable angina within 6 months prior to registration
- New York Heart Association functional classification II, III or IV
- Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate
- Significant lung disease: dyspnea at rest grade 2 or greater (resulting from extensive tumor involvement or other causes), pneumonitis grade 2 or greater, interstitial lung disease grade 2 or greater, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
- Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), uncontrolled interstitial lung disease, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
- Treatment with strong CYP2C8 or CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to registration
- Women who are unwilling to discontinue nursing
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- University of Arkansas for Medical SciencesRecruiting
- Sutter Auburn Faith HospitalRecruiting
- John Muir Medical Center-Concord CampusRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- City of Hope at Huntington BeachRecruiting
- City of Hope at Irvine LennarRecruiting
- Kaiser Permanente-IrvineRecruiting
- City of Hope at Long Beach ElmRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Memorial Medical CenterRecruiting
- Palo Alto Medical Foundation-Gynecologic OncologyRecruiting
- Kaiser Permanente-RiversideRecruiting
- Sutter Roseville Medical CenterRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- California Pacific Medical Center-Pacific CampusRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- City of Hope UplandRecruiting
- John Muir Medical Center-Walnut CreekRecruiting
- UCHealth University of Colorado HospitalRecruiting
- UCHealth - Cherry CreekRecruiting
- North Colorado Medical CenterRecruiting
- UCHealth Highlands Ranch HospitalRecruiting
- Danbury HospitalRecruiting
- Smilow Cancer Hospital Care Center at GlastonburyRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Yale UniversityRecruiting
- Norwalk HospitalRecruiting
- Smilow Cancer Hospital-Waterbury Care CenterRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Sibley Memorial HospitalRecruiting
- Florida Cancer Specialists - Sarasota DowntownRecruiting
- First Physicians Group-SarasotaRecruiting
- Sarasota Memorial HospitalRecruiting
- Florida Cancer Specialists - Venice HealthparkRecruiting
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Augusta University Medical CenterRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Queen's Medical CenterRecruiting
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Northwest Community HospitalRecruiting
- Rush - Copley Medical CenterRecruiting
- Centralia Oncology ClinicRecruiting
- Northwestern UniversityRecruiting
- John H Stroger Jr Hospital of Cook CountyRecruiting
- Rush University Medical CenterRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Sudarshan K Sharma MD Limited-Gynecologic OncologyRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Cancer Care Center of O'FallonRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Northwest Cancer Center - Main CampusRecruiting
- Northwest Oncology LLCRecruiting
- Northwest Cancer Center - HobartRecruiting
- Saint Mary Medical CenterRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- Franciscan Health IndianapolisRecruiting
- Ascension Saint Vincent Indianapolis HospitalRecruiting
- Saint Catherine HospitalRecruiting
- Franciscan Health MooresvilleRecruiting
- The Community HospitalRecruiting
- Women's Diagnostic Center - MunsterRecruiting
- Memorial Hospital of South BendRecruiting
- Northwest Cancer Center - ValparaisoRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - Trinity Cancer CenterRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Baptist Health LexingtonRecruiting
- Baptist Health LouisvilleRecruiting
- LSU Health Baton Rouge-North ClinicRecruiting
- Our Lady of the Lake Physicians Group - Medical OncologyRecruiting
- Our Lady of the Lake Medical OncologyRecruiting
- East Jefferson General HospitalRecruiting
- University Medical Center New OrleansRecruiting
- Ochsner Baptist Medical CenterRecruiting
- Ochsner Medical Center JeffersonRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Greater Baltimore Medical CenterRecruiting
- Sinai Hospital of BaltimoreRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Walter Reed National Military Medical CenterRecruiting
- William E Kahlert Regional Cancer Center/Sinai HospitalRecruiting
- Baystate Medical CenterRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Beaumont Hospital - Farmington HillsRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Spectrum Health Reed City HospitalRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Marie Yeager Cancer CenterRecruiting
- Munson Medical CenterRecruiting
- William Beaumont Hospital - TroyRecruiting
- University of Michigan Health - WestRecruiting
- Mercy HospitalRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Abbott-Northwestern HospitalRecruiting
- University of Minnesota/Masonic Cancer CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- United HospitalRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital Saint LouisRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- Women's Cancer Center of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Monmouth Medical Center Southern CampusRecruiting
- Saint Barnabas Medical CenterRecruiting
- Monmouth Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Virtua Samson Cancer CenterRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Robert Wood Johnson University Hospital SomersetRecruiting
- Virtua VoorheesRecruiting
- University of New Mexico Cancer CenterRecruiting
- Presbyterian Kaseman HospitalRecruiting
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- NYU Winthrop HospitalRecruiting
- Mount Sinai ChelseaRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Mount Sinai HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Duke Cancer Institute CaryRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Duke University Medical CenterRecruiting
- Novant Health New Hanover Regional Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Aultman Health FoundationRecruiting
- Miami Valley Hospital SouthRecruiting
- Geauga HospitalRecruiting
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel East HospitalRecruiting
- Riverside Methodist HospitalRecruiting
- The Mark H Zangmeister CenterRecruiting
- Miami Valley HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical CenterRecruiting
- Marietta Memorial HospitalRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- Knox Community HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- ProMedica Flower HospitalRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Saint Ann's HospitalRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Oklahoma Cancer Specialists and Research Institute-TulsaRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Legacy Good Samaritan Hospital and Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Legacy Meridian Park HospitalRecruiting
- Bryn Mawr HospitalRecruiting
- Saint Vincent HospitalRecruiting
- Jefferson HospitalRecruiting
- Riddle Memorial HospitalRecruiting
- Forbes HospitalRecruiting
- Paoli Memorial HospitalRecruiting
- Pennsylvania HospitalRecruiting
- Thomas Jefferson University HospitalRecruiting
- West Penn HospitalRecruiting
- Chester County HospitalRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Asplundh Cancer PavilionRecruiting
- Lankenau Medical CenterRecruiting
- Women and Infants HospitalRecruiting
- Saint Joseph's/Candler - Bluffton CampusRecruiting
- Medical University of South CarolinaRecruiting
- Avera Cancer Institute-AberdeenRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- The West Clinic - Wolf RiverRecruiting
- Parkland Memorial HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- Houston Methodist HospitalRecruiting
- Methodist Willowbrook HospitalRecruiting
- Houston Methodist West HospitalRecruiting
- Houston Methodist Saint John HospitalRecruiting
- Houston Methodist Sugar Land HospitalRecruiting
- Houston Methodist The Woodlands HospitalRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- South Jordan Health CenterRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Carilion Clinic Gynecological OncologyRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Swedish Medical Center-First HillRecruiting
- Legacy Salmon Creek HospitalRecruiting
- West Virginia University Charleston DivisionRecruiting
- West Virginia University HealthcareRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Medical College of WisconsinRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- Saint Vincent Hospital Cancer Center at SheboyganRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Centro Comprensivo de Cancer de UPRRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (paclitaxel, carboplatin)
Arm II (paclitaxel, carboplatin, Herceptin Hylecta)
Arm III (paclitaxel, carboplatin, Phesgo)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. Patients undergo ECHO or MUGA scan at end of treatment and every 6 months for 2 years.
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance therapy for up to 3 years from the start of treatment. Patients undergo ECHO or MUGA scan at end of treatment and every 6 months for 2 years.
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and pertuzumab/trastuzumab/hyaluronidase-zzxf SC over 5-8 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive pertuzumab/trastuzumab/ hyaluronidase-zzxf SC over 5 minutes on day 1. Cycles repeat every 3 weeks for up to 1 year in absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance for up to 3 years from the start of treatment. Patients undergo ECHO or MUGA scan at end of treatment and every 6 months for 2 years.