- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179904
TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer
Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the overall tumor response rate (ORR i.e. complete response [CR]+partial response [PR]) of the combination of FASN inhibitor TVB-2640 [TVB-2640] with paclitaxel and trastuzumab in patients with taxane and trastuzumab-resistant, advanced HER2-positive breast cancer.
II. To estimate the ORR of the combination of TVB-2640 with paclitaxel and trastuzumab in patients with taxane and trastuzumab-resistant, advanced HER2-positive breast cancer.
SECONDARY OBJECTIVES:
I. For each patient cohort, to evaluate the safety profile of the combination of TVB-2640 with paclitaxel and trastuzumab.
II. For each patient cohort, to assess the clinical benefit rate (CBR), duration of response, and progression free survival of the combination of TVB-2640 with paclitaxel and trastuzumab.
III. To obtain a point and interval estimate of the difference in RR as well as the difference in CBR between cohort A and cohort B.
CORRELATIVE RESEARCH OBJECTIVES:
I. For each patient cohort, to assess the changes in FASN, phosphorylation (p)AKT, and pS6 expression in tumor tissue after the first cycle of the combination of TVB-2640 with paclitaxel and trastuzumab from pre-treatment levels.
II. For each patient cohort, to assess the changes in levels of cellular apoptosis in tumor tissue after the first cycle of the combination of TVB-2640 with paclitaxel and trastuzumab from pre-treatment levels.
III. For each patient cohort, to assess the changes in serum FASN after the first cycle of the combination of TVB-2640 with paclitaxel and trastuzumab from pre-treatment levels.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients receive FASN inhibitor TVB-2640 orally (PO) once daily (QD) on days 1-28, paclitaxel intravenously (IV) over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22, and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo echocardiography (ECHO) and computed tomography (CT) or magnetic resonance imaging (MRI) at screening and on study and undergo collection of blood samples and biopsy on study.
COHORT B: Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued. Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant intramuscularly (IM) on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
After completion of study treatment, patients are followed up every 6 months for up to 3 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PRE-REGISTRATION INCLUSION CRITERIA
- Age >=18 years
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria that is:
- A non-nodal lesion is considered measurable if its longest diameter can be accurately measured as >= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) and/or
- A malignant lymph node is considered measurable if its short axis is > 1.5 cm when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm)
- Note: tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible
- Received =< six (6) prior chemotherapy regimens in the metastatic setting
Cohort A one of the following must be true:
Distant disease progression during administration of combination therapy with taxane based chemotherapy and anti-HER2 therapy (trastuzumab or pertuzumab) for metastatic disease
- Note: patients who began treatment with this combination and discontinued taxane-based chemotherapy due to intolerability before distant disease progression are eligible
Distant disease progression during administration or within 180 days of discontinuing combination therapy with taxane based chemotherapy and anti-HER2 therapy (trastuzumab or pertuzumab) in the adjuvant disease
- Note: patients who began treatment with this combination and discontinued taxane-based chemotherapy due to intolerability before distant disease progression are eligible
- For patient who received taxane based chemotherapy and anti-HER2 therapy (trastuzumab or pertuzumab) in the neo-adjuvant setting and underwent surgical resection of primary breast disease: distant disease progression during or within 180 days of discontinuing anti-HER2 therapy (trastuzumab or pertuzumab) in the adjuvant setting
Cohort B (one of the following must be true):
Distant disease progression during administration of combination therapy with endocrine therapy and anti-HER2 therapy (trastuzumab or pertuzumab) for metastatic disease; permissible endocrine therapies include an aromatase inhibitor or fulvestrant
- NOTE: Tamoxifen is not permissible
Distant disease progression during administration of combination therapy with endocrine therapy and anti-HER2 therapy (trastuzumab or pertuzumab) in the adjuvant setting; permissible endocrine therapies include an aromatase inhibitor or fulvestrant
- NOTE: Tamoxifen is not permissible
Willingness to provide mandatory tumor tissue specimens for correlative research
NOTE: If insufficient or no tissue is obtained by the pre-registration biopsy, an archival tissue specimen (preferably from a metastatic site) from procedure performed =< 5 years prior to pre-registration must be available to submit for Central Laboratory review prior to registration
- Exception: If there is no medically safe site for biopsy, Study Chair (Dr. Haddad) may waive this requirement
- REGISTRATION INCLUSION CRITERIA
- Registration must be completed =< 28 days of pre-registration
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Histological confirmation of HER2-expression (immunohistochemistry [IHC] 1-3+) on pre-registration biopsy. (HER2+ is defined by 2018 American Society of Clinical Oncology/College of American Pathologists [ASCO/CAP] guidelines)
NOTE: If pre-registration biopsy is HER2- by ASCO/CAP guidelines then both of the following must be true:
- The patient's most recent prior biopsy (prior to the pre-registration biopsy) must be HER2+, AND
- The managing provider must be planning to treat the patient with anti-HER2 therapy
- For Cohort B only: Histologic confirmation of ERalpha positive disease (>= 1% expression)
- Hemoglobin >= 9.0 g/dL (obtained =< 14 days prior to registration)
- Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration)
- Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)
- Direct bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)
- Aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement) (obtained =< 14 days prior to registration)
- Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
- Cardiac ejection fraction (left ventricular ejection fraction [LVEF]) >= 50% by echocardiogram =< 28 days prior to registration
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of TVB-2640, as follows:
- For women: Compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile or postmenopausal
- For men: Compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile; men whose sexual partners are of child-bearing potential must agree to use 2 methods of contraception prior to study entry, during the study, and for 3 months after the treatment period
- Willingness to provide mandatory tumor tissue and/or blood specimens for correlative research
Exclusion Criteria:
- PRE-REGISTRATION EXCLUSION CRITERIA
- Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
- Patients with a history of LVEF decline to below 50% during or after prior trastuzumab or other HER2 directed therapy =< 6 months prior to pre-registration
- Patients with any class of New York Heart Association (NYHA) congestive heart failure (CHF) or heart failure with preserved ejection fraction (HFPEF)
- Patients with a history of known coronary artery disease or a myocardial infarction within 12 months prior to pre-registration
- Patients with persistently uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical therapy
- Patients with known unstable angina pectoris
- Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
- Patients with a prolonged corrected QT interval (QTc) interval (>= 450 ms)
Leptomeningeal disease or uncontrolled brain metastasis
- NOTE: Metastases treated by surgery and/or radiotherapy such that patient is neurologically stable and off steroids >= 4 weeks prior to preregistration are eligible
Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
- EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
- Tumors involving spinal cord or heart
Visceral crisis or lymphangitic spread
- NOTE: Visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease
Uncontrolled intercurrent non-cardiac illness including, but not limited to,
- Ongoing or active infection
- Psychiatric illness/social situations
- Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
- Or any other conditions that would limit compliance with study requirements
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Prior history of hypersensitivity, drug or radiation-induced, or other immune-mediated pneumonitis
- Patient is unable to swallow oral medications or has impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption (e.g. active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome); note: concomitant therapy with proton pump inhibitors and/or H2-receptor antagonists is permissible
- Patient has a history of clinically significant dry eye (xerophthalmia) or other corneal abnormality, or if a contact lens wearer, does not agree to abstain from contact lens use from baseline through the last TVB-2640 dose
- Patients with a history of intolerance to trastuzumab (i.e. a grade 3 or 4 infusion reaction) are excluded; Note: patients with a history of mild infusion reaction to trastuzumab who have previously been successfully re-challenged after an infusion reaction with or without prophylactic medication are allowed
Other invasive malignancy =< 3 years prior to pre-registration
- EXCEPTIONS: Non-melanoma skin cancer, papillary thyroid cancer, or carcinoma-in-situ of the cervix which has been adequately treated
- NOTE: If there is a history of prior malignancy, patients must not be receiving other treatment for their cancer and the disease must be inactive/stable
- REGISTRATION EXCLUSION CRITERIA
Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Any of the following therapies prior to registration:
- Chemotherapy =< 3 weeks
- Immunotherapy =< 3 weeks
- Biologic therapy =< 3 weeks
- Monoclonal antibodies =< 3 weeks
- Radiation therapy =< 2 weeks
- CDK 4/6 inhibitors =< 4 weeks
- mTOR inhibitors =< 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A (FASN inhibitor TVB-2640, paclitaxel, trastuzumab)
Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28, paclitaxel IV over 1-96 hours on days 1, 8, and 15, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued.
Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity.
Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
|
Given IV
Other Names:
Undergo MRI
Other Names:
Given IV
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo biopsy
Other Names:
Undergo ECHO
Other Names:
Given PO
Other Names:
|
Experimental: Cohort B (TVB-2640, trastuzumab, endocrine therapy)
Patients receive FASN inhibitor TVB-2640 PO QD on days 1-28 and trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and optionally every 21 days after 3 cycles and paclitaxel is discontinued.
Patients also continue endocrine therapy of either anastrozole PO QD, exemestane PO QD, fulvestrant IM on days 1 and 14 of cycle 1 and day 1 of subsequent cycles, or letrozole PO QD.
Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity.
Patients also undergo ECHO and CT or MRI at screening and on study and undergo collection of blood samples and biopsy on study.
|
Given IV
Other Names:
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo biopsy
Other Names:
Undergo ECHO
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given IM
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Up to 3 years
|
Will be defined as the number of patients whose disease meets the Response Evaluation Criteria in Solid Tumors criteria for a partial or complete response on two consecutive evaluations at least 8 weeks apart divided by the total number of patients in that cohort who started protocol treatment.
For each cohort, a two-stage Simon minimax design with a safety run-in period will be used to test the null hypothesis that the true tumor response rate is at most 5% against the alternative it is at least 20%.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response
Time Frame: Up to 3 years
|
Will be defined as the time from the first radiologic finding of a partial response or complete response to disease progression among those patients whose disease meets the Response Evaluation Criteria in Solid Tumors criteria for complete response or partial response on 2 consecutive evaluations approximately 8 weeks apart.
A point and interval estimate of the response rate as well as the clinical benefit rate will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design.
The distribution of response times and progression-free survival times will be estimated using the Kaplan-Meier approach.
|
Up to 3 years
|
Clinical benefit rate
Time Frame: Up to 3 years
|
Will be defined as the proportion of patients who have completed 6 cycles of treatment without disease progression (that is, their objective disease status is a complete response, partial response, or stable for 6 cycles or more).
A point and interval estimate of the response rate as well as the clinical benefit rate will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design.
The distribution of response times and progression-free survival times will be estimated using the Kaplan-Meier approach.
|
Up to 3 years
|
Progression free survival
Time Frame: Up to 3 years
|
Will be defined as time from randomization to the first of these disease events: local/regional or distant breast recurrence, ductal breast carcinoma in situ or invasive breast disease in contralateral breast, non-breast second primary, or death due to any cause.
A point and interval estimate of the response rate as well as the clinical benefit rate will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design.
The distribution of response times and progression-free survival times will be estimated using the Kaplan-Meier approach.
|
Up to 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in biomarker expression
Time Frame: Baseline up to 28 days
|
The changes in H score FASN, pAKT, and pS6 expression and levels of cellular apoptosis in tumor tissue will be examined graphically by plotting the difference in pre and post levels against pre-levels of the biomarker, with patients who derived clinical benefit represented by dashed line and those who did not by solid line.
For each patient cohort, Wilcoxon signed rank tests will be used to assess the changes in serum FASN.
|
Baseline up to 28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tufia C. Haddad, M.D., Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Breast Neoplasms
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Paclitaxel
- Trastuzumab
- Immunoglobulins
- Letrozole
- Fulvestrant
- Albumin-Bound Paclitaxel
- Trastuzumab biosimilar HLX02
- Anastrozole
- Exemestane
- Immunoglobulin G
Other Study ID Numbers
- MC1633 (Mayo Clinic in Rochester)
- P30CA015083 (U.S. NIH Grant/Contract)
- NCI-2017-00944 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 16-010066 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anatomic Stage III Breast Cancer AJCC v8
-
M.D. Anderson Cancer CenterCompletedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
University of California, San FranciscoTerminatedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterRecruitingBreast Cancer | Anatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
University of WashingtonUnited States Department of DefenseRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBreast Cancer | Anatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
Clinical Trials on Trastuzumab
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingBreast Ductal Carcinoma In SituUnited States, Canada, Puerto Rico, Korea, Republic of
-
Tanvex BioPharma USA, Inc.CompletedBreast Cancer | Breast Neoplasms | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Early-stage Breast CancerBelarus, Chile, Georgia, Hungary, India, Mexico, Peru, Philippines, Russian Federation, Ukraine
-
Spanish Breast Cancer Research GroupCompleted
-
Fudan UniversityHoffmann-La RocheUnknown
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHER2-positive Breast Cancer | Early-stage Breast Cancer | Adjuvant Treatment After Trastuzumab | RCB Classification 1-2 | NeratiniChina
-
Orano Med LLCCompletedStomach Neoplasms | Breast Neoplasms | Pancreatic Neoplasms | Ovarian Neoplasms | Peritoneal NeoplasmsUnited States
-
National Cancer Institute (NCI)Active, not recruitingMale Breast Carcinoma | Stage IIA Breast Cancer AJCC v6 and v7 | Stage IIB Breast Cancer AJCC v6 and v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7United States, Puerto Rico
-
Samsung Bioepis Co., Ltd.TerminatedBreast NeoplasmsUkraine, Romania, Russian Federation, France, Bulgaria, Czechia, Poland
-
University Medical Center GroningenCompleted
-
Fudan UniversityCompleted