ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03250676
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( H3 Biomedicine Inc. )

Brief Summary:

Phase 1 of the study will be conducted to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Phase 2 of the study will be conducted to estimate the efficacy of H3B-6545 in terms of response rate, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants and in participants with and without the estrogen receptor alpha (ERα) mutation.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: H3B-6545 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1: ERα^WT
H3B-6545 capsules will be administered orally (PO) to all estrogen receptor alpha (ERα) wild type participants at their assigned dose, once daily (QD) in an open-label fashion. The starting dose of H3B-6545 will be 100 milligrams (mg) QD PO. Participants will be instructed to take the dose on an empty stomach (no food 2 hours before or 2 hours after dose) (with the exception of participants taking the fed dose of the food-effect cohort) at approximately the same time each morning.
Drug: H3B-6545
Oral Capsules
Experimental: Arm 2: ERα^mut
H3B-6545 capsules will be administered orally (PO) to all ERα mutant participants at their assigned dose, once daily (QD) in an open-label fashion. The starting dose of H3B-6545 will be 100 milligrams (mg) QD PO. Participants will be instructed to take the dose on an empty stomach (no food 2 hours before or 2 hours after dose) (with the exception of participants taking the fed dose of the food-effect cohort) at approximately the same time each morning.
Drug: H3B-6545
Oral Capsules



Primary Outcome Measures :
  1. Phase 1: Number of participants with dose-limiting toxicities (DLTs), as a function of the dose of H3B-6545 for determination of the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) [ Time Frame: Up to 28 days (Cycle 1) ]
    The MTD is the highest dose of a drug or product that doesn't cause unacceptable side effects. The Investigator will review all participants' safety and clinical data to jointly determine the MTD/RP2D of H3B-6545. During dose escalation if 2 out of 6 participants experience DLTs (side effects that prevent a dose increase) at a given dose level during Cycle 1 of the therapy, then the MTD has been exceeded and dose escalation will be stopped. The RP2D is determined based on the MTD.

  2. Phase 2: Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]
    ORR is the proportion of participants achieving a best overall response (BOR) of confirmed partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. It is determined by investigator review. The BOR is the best response recorded from the start of the treatment until disease progression/recurrence. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions.


Secondary Outcome Measures :
  1. Phase 1 and Phase 2: Number of participants with any treatment-emergent (TE) serious adverse event (SAE) [ Time Frame: Up to 3 years ]
    An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (i.e, the participant was at immediate risk of death from the adverse event [AE] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  2. Phase 1 and Phase 2: Number of participants with any non-serious TEAE [ Time Frame: Up to 3 years ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  3. Phase 1 and Phase 2: Number of participants with an abnormal, clinically significant clinical laboratory value [ Time Frame: Up to 3 years ]
    Laboratory results will be summarized using Systeme International (SI) units, as appropriate. Clinical significance will be determined by the Investigator.

  4. Phase 1 and Phase 2: Number of participants with an abnormal, clinically significant vital sign value [ Time Frame: Up to 3 years ]
    Clinical significance will be determined by the Investigator.

  5. Phase 1 and Phase 2: Number of participants with an abnormal, clinically significant 12-lead electrocardiogram (ECG) finding [ Time Frame: Up to 3 years ]
    ECG assessments will be performed throughout the study, and abnormalities will be listed on a per-participant basis. Clinical significance will be determined by the Investigator.

  6. Phase 1: Mean area under the plasma concentration-time curve from time point 0 through the last measurable point (AUC0-t) [ Time Frame: Cycle 1: Days 1 and 15 (pre-dose; 0.5 hours [hr], 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose), and at pre-dose on Days 8 and 22 ]
    Area under the curve (AUC) represents the total drug exposure over a defined period of time after administration.

  7. Phase 1: Mean maximum observed plasma concentration (Cmax) [ Time Frame: Cycle 1: Days 1 and 15 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose), and at pre-dose on Days 8 and 22 ]
    Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.

  8. Phase 1: Mean time of maximum observed plasma concentration (tmax) [ Time Frame: Cycle 1: Days 1 and 15 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose), and at pre-dose on Days 8 and 22 ]
    Tmax is defined as the time from dosing to reach the maximum observed concentration that a drug achieves in a specified compartment or test area of the body.

  9. Phase 1: Mean accumulation ratio (Racc) [ Time Frame: Cycle 1: Days 1 and 15 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose), and at pre-dose on Days 8 and 22 ]
    Racc is the rate and extent of accumulation of drug in the plasma.

  10. Phase 1: ORR [ Time Frame: Up to 3 years ]
    ORR is the proportion of participants achieving a BOR of confirmed PR or CR per RECIST 1.1. It is determined by investigator review. The BOR is the best response recorded from the start of the treatment until disease progression/recurrence. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions.

  11. Phase 1 and Phase 2: Duration of response (DoR) [ Time Frame: Up to 3 years ]
    DoR is the time from the date of first documented CR/PR until the first documentation of confirmed disease progression as determined by the investigator or death, whichever comes first. As per RECIST 1.1, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and CR is defined as the disappearance of all target lesions. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions; taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

  12. Phase 1 and Phase 2: Disease control rate (DCR) [ Time Frame: Up to 3 years ]
    DCR is the proportion of participants achieving a best response of CR, PR, or stable disease (SD). As per RECIST 1.1, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions, and SD is defined as the persistence of one or more non-target lesions and/or the persistence of tumor marker level above the normal limits.

  13. Phase 1 and Phase 2: Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
    PFS is the time from the first dose date to the date of the first documentation of confirmed disease progression as determined by the investigator or death (whichever occurs first). Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions; taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

  14. Phase 1 and Phase 2: Overall survival (OS) [ Time Frame: Up to 3 years ]
    OS is the time from the first dose date to the date of death (event) or the date on which the participant was last known to be alive (censored).

  15. Phase 2: Relative bioavailability of H3B-6545 due to moderate-fat meal [ Time Frame: Up to 3 years ]
    Bioavailability of a drug is the proportion of the drug which enters the circulation when introduced into the body and thus is able to have an active effect.

  16. Phase 2: Change from Baseline in mean endometrial thickness [ Time Frame: Baseline, Week 12, and after every 24 weeks up to 3 years ]
    Participants with an intact uterus will undergo an assessment of endometrial thickness using transvaginal ultrasound.

  17. Phase 2: Change from Baseline in mean uterine volume [ Time Frame: Baseline, Week 12, and after every 24 weeks up to 3 years ]
    Participants with an intact uterus will undergo an assessment of uterine volume using transvaginal ultrasound.

  18. Phase 2: Mean concentration of bone-specific alkaline phosphatase (BSAP) in serum [ Time Frame: Screening, Cycle 1 Day 1, Cycle 2 Day 15, and Cycle 4 Day 1 ]
    Serum BSAP is a glycoprotein localized in the plasma membrane of osteoblasts. It is an indicator of the metabolic status of osteoblasts in human serum.

  19. Phase 2: Mean concentration of amino-terminal propeptide of type 1 collagen (PINP) in serum [ Time Frame: Screening, Cycle 1 Day 1, Cycle 2 Day 15, and Cycle 4 Day 1 ]
    PINP is a clinical indicator of bone turnover and the extent of metastatic spread in osseous metastatic breast cancer. Its assessment will monitor bone formation in participants.

  20. Phase 2: Mean concentration of C-terminal cross-linking telopeptide of type 1 collagen (CTX) in serum [ Time Frame: Screening, Cycle 1 Day 1, Cycle 2 Day 15, and Cycle 4 Day 1 ]
    CTX is a biomarker of bone resorption.

  21. Phase 2: Mean AUC0-t under fasting condition [ Time Frame: Cycle 1 Day 15 ]
    AUC represents the total drug exposure over a defined period of time after administration.

  22. Phase 2: Mean AUC0-t under fed condition [ Time Frame: Cycle 1: Days 15 and 22 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose) ]
    AUC represents the total drug exposure over a defined period of time after administration.

  23. Phase 2: Mean Cmax under fasting condition [ Time Frame: Cycle 1 Day 15 ]
    Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.

  24. Phase 2: Mean Cmax under fed condition [ Time Frame: Cycle 1: Days 15 and 22 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose) ]
    Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.

  25. Phase 2: Mean Tmax under fasting condition [ Time Frame: Cycle 1 Day 15 ]
    Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body.

  26. Phase 2: Mean Tmax under fed condition [ Time Frame: Cycle 1: Days 15 and 22 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose) ]
    Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body.

  27. Phase 2: Mean Racc under fasting condition [ Time Frame: Cycle 1 Day 15 ]
    Racc is the rate and extent of accumulation of drug in the plasma.

  28. Phase 2: Mean Racc under fed condition [ Time Frame: Cycle 1: Days 15 and 22 (pre-dose; 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, and 24 hr post-dose) ]
    Racc is the rate and extent of accumulation of drug in the plasma.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has signed informed consent form (ICF) before any trial related activities and according to local guidelines.
  • Only females are eligible. Menopausal status:

    i. Postmenopausal defined by:

    1. Prior bilateral oophorectomy;
    2. Age ≥60 years; or
    3. Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and follicle-stimulating hormone (FSH) value >40 milli-international units per milliliter (mIU/mL) and an estradiol value <40 picograms per milliliter (pg/mL) (140 picomoles per liter [pmol/L]).

      Or ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH during the study.

  • Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor (ER) positive breast cancer by local laboratory.
  • Participant has human epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by American Society of Clinical Oncology (ASCO)-College of American Pathologists guidelines.
  • Participant must have progressed on the most recent therapy.
  • Prior therapy for breast cancer in the advanced/metastatic setting must have included at least:

    1. two prior hormonal therapies;
    2. one prior hormonal therapy and one prior chemotherapy regimen; or
    3. one prior hormonal therapy and a Cyclin-dependent kinase (CDK)4/6 inhibitor. Note: Participants may have received treatment for brain metastases, but must be neurologically stable, completed radiotherapy and off corticosteroids for at least one month prior to starting trial therapy.
  • Participant must have at least one biopsiable lesion in the Phase 1 portion. In the Phase 2 part of the trial, participants must have either (a) at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or (b) at least one predominantly lytic bone lesion.
  • Participant must be willing to undergo tumor biopsies prior to treatment and on Cycle 2 Day 1. In the Phase 2 part of the trial, participants with bone-only disease, or participants for whom a biopsy is contra-indicated, may opt out of providing tumor biopsies. Note: A subset of participants in Phase 2 will be required to provide tumor tissue until tumor pairs have been collected from at least 15 ER˄WT and 15 ER˄mut (determined by sponsor-designated central laboratory test).
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Participant has adequate bone marrow and organ function as defined by the following laboratory values:

    1. Absolute neutrophil count (ANC) ≥1.5 × 10˄9/Liter (L);
    2. Platelets ≥100 × 10˄9/L;
    3. Hemoglobin ≥9.0 grams per deciliter (g/dL);
    4. Potassium, sodium, calcium (corrected for serum albumin), magnesium, and phosphorus within normal limits for the institution;
    5. International normalized ratio (INR) ≤1.5;
    6. Serum creatinine ≤1.5 × upper limit of normal (ULN);
    7. Serum albumin ≥3.5 g/dL (≥35 grams per liter (g/L));
    8. In the absence of liver metastases, alanine aminotransferase (AST) and aspartate aminotransferase (ALT) should be below 3.0 × ULN. If the participant has liver metastases, ALT and AST should be below 5.0 × ULN.
    9. Total serum bilirubin less than ULN.
  • Willingness and ability to comply with study and follow-up procedures.
  • Ability to understand the nature of this study and give written informed consent.

Exclusion Criteria:

  • Participant with bone-only disease (Phase 1 only). Note: Phase 2 participants may have predominantly lytic bone-only disease.
  • Participant with inflammatory breast cancer.
  • Participant has received more than one prior chemotherapy regimen for metastatic disease.
  • Participant has had prior antineoplastic therapy within 14 days prior to starting study drug.
  • Participant is currently receiving or has received systemic corticosteroids ≤2 weeks prior to starting study drug, or has not fully recovered from side effects of such treatment.

Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops, or local injections (e.g., intra-articular).

  • Participant has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to Grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or for whom ≥30% of the bone marrow was irradiated.
  • Major surgical procedures ≤14 days of beginning study drug, or minor surgical procedures ≤7 days, or has not recovered from major side effects. No waiting required following port-a-cath placement.
  • Participant has active cardiac disease or a history of cardiac dysfunction including any of the following:

    1. History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry;
    2. History of documented congestive heart failure (New York Heart Association functional classification III-IV);
    3. Documented cardiomyopathy;
    4. Participant has a left ventricular ejection fraction (LVEF) <50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO);
    5. History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;
    6. On screening, any of the following cardiac parameters: interval between P and R (PR interval) >220 milliseconds (msec), interval between Q, R, and S (QRS) interval >109 msec, or QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec;
    7. Systolic blood pressure (BP) not deemed clinically controlled by the investigator.
  • Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of H3B-6545 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Participant has a known hypersensitivity to any of the excipients of H3B-6545.
  • Participant has a known history of human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV), or requires treatment with protease inhibitors (testing not mandatory).
  • Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate participant participation in the clinical study (e.g., chronic pancreatitis, active hepatitis, etc.).
  • Participant that received in the 7 days prior to the administration of study drug or is currently receiving any of the following medications:

    1. Known strong inducers or inhibitors of cytochrome (CYP)3A4 or P-glycoprotein (P-gp);
    2. Medications that have a known risk to prolong the QT interval or induce Torsades de Pointes;
    3. Proton-pump inhibitors and histamine H2-receptor antagonists;
    4. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP2C8, CYP2C9, CYP2C19, or CYP3A4;
    5. Herbal preparations/medications. These herbal medications include, but are not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
  • Any adverse events related to previous therapies for breast cancer that have not resolved to ≤Grade 1.
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per liter [IU/L] or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • Females of childbearing potential who:

    1. Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
    2. Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
    3. Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
    4. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
  • Alcohol dependency within 6 months before study entry
  • Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250676


Contacts
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
United States, Florida
Florida Cancer Specialists and Research Institute Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
H3 Biomedicine Inc.

Responsible Party: H3 Biomedicine Inc.
ClinicalTrials.gov Identifier: NCT03250676     History of Changes
Other Study ID Numbers: H3B-6545-A001-101
BRE 287 ( Other Identifier: Sarah Cannon Development Innovations, LLC )
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eisai Inc. ( H3 Biomedicine Inc. ):
HER2
estrogen receptor alpha
H3B-6545
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs