Breast Cancer Clinical Trial
— NATUREOfficial title:
Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer
This is an open label, neoadjuvant phase II study to evaluate the objective response, toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be intravenously administered every 3 weeks for a total of 6 weeks. Patients who achieve a partial or complete response after the 6-week treatment (responders) will continue on trastuzumab emtansine for an additional 12 weeks.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female gender; - Age =18 years; - Eastern Cooperative Oncology Group performance status of 0-1; - Histologically confirmed invasive breast cancer; - Primary tumor greater than or equal to 1 cm diameter, as measured by clinical examination and mammography or ultrasound; - Any N; - No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed); - HER2 low or equivocal status in the invasive component of the primary tumor (confirmed by a central certified laboratory prior to study entry) - HER2 low expression: 1+/2+ by immunohistochemistry and/or HER2/CEP17 ratio <2.0 with HER2 copy number <6.0 signals/cell - HER2 equivocal expression: HER2 copy number =4.0 and <6.0 signals/cell; - Hematopoietic status: Absolute neutrophil count = 1.0 x 10^9/L, Platelet count = 100 x 10^9/L, Hemoglobin at least 9 g/dL; • Hepatic status: Serum total bilirubin =1 x upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum total bilirubin [< 1.5 x ULN] is allowed), Aspartate aminotransferase and alanine aminotransferase =1.5 x ULN, Alkaline phosphatase = 1.5 x ULN; • Renal status: Creatinine =1.5 mg/dL; - International Normalized Ratio =1.5 x ULN; - Baseline left ventricular ejection fraction =50%, as measured by echocardiography or multigated acquisition scan; - Negative serum or urine ß-human chorionic gonadotropin pregnancy test within 7 days prior study entry for patients of childbearing potential. Women of childbearing potential must use effective contraception (barrier method [condoms, diaphragm] in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, and implantable hormonal contraceptives are not allowed) for the duration of the study and for at least 7 months after the last dose of study treatment; - Signed informed consent form (ICF); - Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol. Exclusion Criteria: - Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and carcinoma in situ of the cervix; - Patients with a prior malignancy diagnosed more than 5 years prior to study entry; - Preexisting peripheral neuropathy = grade 2; - Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (=180/110), unstable diabetes mellitus, dyspnea at rest, or chronic oxygen therapy; - Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety; - Unresolved or unstable serious adverse events from prior administration of another investigational drug; - Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF; - Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy other than the trial therapy); - Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab emtansine or its components; - Ejection fraction <55% or below the lower limit of the institutional normal range; - Pregnant or lactating women; - Concomitant use of cytochrome P450 3A4 inhibitors or inducers; - Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol; - Active infection requiring intravenous or oral antibiotics; - Patients unwilling or unable to comply with the protocol. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Jenny C. Chang, MD | Genentech, Inc., Houston Methodist Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pathological complete response (pCR) rate | Determine the pCR rate of continued trastuzumab emtansine treatment in responders | 18 weeks | No |
Other | pCR rate | Determine the pCR rate of continued trastuzumab emtansine treatment in responders according to estrogen receptor status | 18 weeks | No |
Other | Correlative markers of trastuzumab emtansine response | Explore correlative markers of trastuzumab emtansine response using tumor biopsy specimens | 6 weeks | No |
Primary | Objective response rate | Determine the objective response rate after 6 weeks of neoadjuvant trastuzumab emtansine (RECIST 1.1) | 6 weeks | No |
Secondary | Radiological response | Determine radiological response after 6 weeks of neoadjuvant trastuzumab emtansine | 6 weeks | No |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | 18 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |