ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Hemay022 in Combination With Exemestane In Subjects With ER Positive and HER2 Positive Advanced 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: NCT03308201
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Hemay Pharmaceutical Co.,Ltd

Brief Summary:

The purposes of this study are to assess the safety, tolerability of combining Hemay022 with exemestane in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR( Optimal Tolerated Regimen). The secondary purpose of this study is to assess the pharmacokinetics and efficacy of combining Hemay022 with exemestane.

The study will be conducted in two parts. Part one, trial will be conducted in 15-24 subjects to determine safety and tolerability of combining Hemay022 with exemestane in patients with HER2-positive advanced breast cancer. Part two, approximately 24 additional subjects with ER and HER2-positive advanced breast cancer, are included to better define the tolerability and preliminary efficacy of Hemay022.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Hemay022 Drug: exemestane Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating Hemay022 in Combination With Exemestane In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

Arm Intervention/treatment
Experimental: Hemay022 and Exemestane

Part one: Hemay022 in combination with exemestane will be taken orally once daily. Planned dose escalation of Hemay022 will be 200mg, 300mg,400mg or 500mg daily for 28 days.

Part two: Hemay022 in combination with exemestane will be taken in OTR dose until disease progression, intolerable toxicity or death.

Drug: Hemay022

Part one: Hemay022 tablets will be taken orally once daily in doses of 200mg, 300mg,400mg or 500mg for 28 days in combination with exemestane.

Part two: Hemay022 tablets will be taken in OTR dose group in combination with exemestane.


Drug: exemestane
Part one and Part two: Exemestane will be taken in 25mg once daily.




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: from baseline until 4 weeks after the study day ]

Secondary Outcome Measures :
  1. Objective response rate (complete response rate + partial response rate) according to RECIST v1.1 [ Time Frame: At screening, every 8 weeks of treatment up to 18 months ]
  2. Clinical benefit rate defined as percentage of patients with stable disease (SD) ≥ 6 months/partial response (PR)/complete response (CR). according to RECIST v1.1 [ Time Frame: At screening, every 8 weeks of treatment up to 18 months ]
  3. Progression Free Survival defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria) [ Time Frame: 18 months after treatment initiation ]
  4. Observed maximum concentration of Hemay022 and exemestane [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post-dose on day 1 and day 28 ]
  5. Time of maximum concentration of Hemay022 and exemestane [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post-dose on day 1 and day 28 ]
  6. Area under the plasma concentration versus time curve of Hemay022 and exemestane [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post-dose on day 1 and day 28 ]
  7. Trough Plasma Concentrations of Hemay022 and exemestane [ Time Frame: pre-dose on day 14 ]


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, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Tumor histologically diagnosed breast cancer subjects;
  2. subjects who have failed standard therapy, have Evidence of metastatic or advanced breast cancer;
  3. ER positive(≥1%) and HER2 over-expression by IHC with score of 3+, and/or positive by ISH confirmation, Post-menopausal female subjects who are suitable for exemestane as endocrine therapy ;
  4. Postmenopausal, as defined by any of the following:

    • Prior surgical bilateral ovarian ablation;
    • ≥60 years old;
    • <60 years old, Natural menopause with at least 1 year since last menses, follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range(utilizing ranges from the local laboratory facility) when not received chemotherapy, tamoxifen, toremifene or ovarian ablation for 1 year prior to screening;
    • <60 years old, follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range(utilizing ranges from the local laboratory facility) when receiving tamoxifen or toremifene;
  5. At least measurable tumour lesion as defined by RECIST criteria1.1;
  6. ECOG Performance Status of 0,1;
  7. Life expectancy of at least three months;
  8. Adequate bone marrow, liver, kidney function, meeting the following criteria:

    ANC≥1.5×109/L, HB≥90g/L(permitting blood transfusion), PLT≥80×109/L; TBIL≤1.5×ULN, ALT≤2.5×ULN, AST≤2.5×ULN; (liver metastatic subjects ALT≤5×ULN,AST≤5×ULN) Cr ≤1.5×ULN

  9. Ability to understand and be willing to sign a written informed consent before study entry;
  10. subjects would have good communication with the investigator and could comply with protocol.

Exclusion Criteria:

  1. Have life-threatening visceral metastases , any central nervous system metastases or leptomeninges carcinomatosis;
  2. Received prior exemestane or herceptin(if exemestane or herceptin were used for adjuvant treatment, discontinued for more than 12 months before study entry, is permitted );
  3. Received Letrozole or anastrozole for advanced or metastatic disease as first line therapy, discontinued for less than 4 weeks before study entry;
  4. Have received radiotherapy within 4 weeks prior to study;
  5. Have received more than one chemotherapy regiment for advanced breast cancer(if for adjuvant treatment, discontinued for more than 4 weeks before study entry );
  6. Patients with parenteral nutrition; malabsorption syndrome; or any condition possibly affecting drug absorption or inability to tolerate oral medications;
  7. Use of any drug that inhibits or induces hepatic metabolism of Hemay022 within 2 weeks prior to study and entire study duration, for example CYP3A4 strong inhibitors or strong inducers;
  8. Have known hypersensitivity to the Hemay022, exemestane or any similar drug;
  9. Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram or MUGA scan;
  10. Positive blood for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
  11. Concurrent ≥2 grade diarrheal or ≥2 grade nausea condition;
  12. active infection (ie, requiring intravenous antibiotic or antiviral agent);
  13. uncontrolled hypertension (systolic pressure >150 mmHg, diastolic pressure >100 mmHg after anti- hypertension therapy);
  14. significant heart disease, including ischemic heart disease (NYHA III-IV), history of myocardial infarction or uncontrolled angina within 6 months, occurrence congestive heart failure within 3 months;
  15. arrhythmias requiring treatment , including atrial fibrillation, supraventricular tachycardia ,ventricular tachycardia, ventricular fibrillation, or patients with coronary heart disease have symptoms requiring medicine treatment, myocardial infarction within 1 year, congestive heart failure (CHF);
  16. confirmed ECG abnormality, including QTc (corrected for heart rate according to either Bazett's formula or to Fridericia's formula) prolong (≥450msec), QRS>120ms;
  17. History of hemorrhagic or thrombus events within 6 months, for example cerebrovascular accident(including transient ischemic attack), pulmonary embolism, tumor Spontaneous bleeding;
  18. Have received other clinical trials treatment or other targeting agents within the 4 weeks prior to study;
  19. Major Surgery or injury less than 4 weeks prior to study;
  20. Other chemotherapy, target therapy, hormone therapy, immunotherapy, radiotherapy(except Symptomatic local radiotherapy ) during the study;
  21. Any other malignant cancer within 5 years with the exception of adequately treated cervical cancer in situ or basal and squamous cutaneous cell carcinomas;
  22. History of alcohol or drug abuse;
  23. serious psychogenic disorders,;
  24. Evidence of significant medical illness or abnormal laboratory finding that would make the subject inappropriate for this study by the investigator's judgment;
  25. Subjects cannot complete the study due to other reasons.

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): NCT03308201


Contacts
Contact: Huiping Li 13811012595 huipingli2012@hotmail.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Huiping Li         
Sponsors and Collaborators
Tianjin Hemay Pharmaceutical Co.,Ltd
Investigators
Principal Investigator: Huiping Li Beijing Cancer Hospital

Responsible Party: Tianjin Hemay Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT03308201     History of Changes
Other Study ID Numbers: HM022BC1C01
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs