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Breast CancerPhase 1NCT03308201

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer

A Phase 1 study testing Hemay022+exemestane, Hemay022+letrozole and Hemay022+ fulvestrant in people with Breast Cancer, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated regimen). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Hemay022+exemestane, Hemay022+letrozole and Hemay022+ fulvestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
16 Oct 2017to 1 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Breast cancer subjects diagnosed by tumor histology;
  • Objective evidence shows that patients with metastasis or relapse who cannot be cured by standard treatment;
  • ER positive (≥1%) and HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive), Post-menopausal female subjects who are suitable for exemestane as endocrine therapy ; Remarks: The expansion period is planned to include 6 subjects combined with letrozole and 6 subjects combined with fulvestrant in the 400mg dose group. Therefore, for this part of the subjects, the expansion period is included " Post-menopausal female subjects who are suitable for letrozole or fulvestrant as endocrine therapy";
  • Postmenopausal is defined as meeting any one of the following four conditions:
  • Past bilateral oophorectomy;
  • Age ≥60 years old;
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  • Age <60 years old, natural menopause ≥12 months, in the past 1 year without chemotherapy, tamoxifen, toremifene or ovarian castration, the level of follicle stimulating hormone (FSH) and estradiol Within the postmenopausal range (use the reference range of the local laboratory).
  • Patients younger than 60 years old who are taking tamoxifen or toremifene, their FSH and estradiol levels are within the postmenopausal range (use the reference range of the local laboratory); Remarks: Premenopausal or perimenopausal women who do not meet the above-mentioned menopausal criteria can also be included in this study, but they must also receive zoladex ovarian suppression therapy. Ovarian suppression therapy has been started at least 14 days before the start of this program, and Must be continued during the treatment plan; For subjects whose postmenopausal status is difficult to judge, the investigator and medical personnel of the sponsor will determine whether to enter the group after discussion.
  • At least one evaluable tumor lesion (according to RECIST1.1) or only bone metastases;
  • ECOG Performance Status of 0-1;
  • The estimated survival time is more than 3 months;
  • Bone marrow function meets: ANC≥1.5×109/L, HB≥90 g/L (allowed for blood transfusion), PLT≥80×109/L. Liver function satisfies: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN (ALT≤5×ULN, AST≤5×ULN in patients with liver metastases); renal function satisfies: blood creatinine ≤1.5×ULN;
  • Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;
  • The subject can communicate well with the investigator and can complete the research in accordance with the research regulations.

Who cannot join

  • There are life-threatening visceral metastases, any central nervous system metastases or leptomeninges carcinomatosis;
  • Have received exemestane for breast cancer treatment (Note: If exemestane was previously used in the adjuvant treatment stage, and the drug has been stopped for ≥12 months before this enrollment, you can join the group); Remarks: For subjects who have been combined with letrozole in the extended phase, if they have received letrozole to treat breast cancer, they need to be excluded (if letrozole is used in the adjuvant treatment phase, and the drug has been stopped for ≥12 months before this enrollment , You can be included in the group); for subjects who have been combined with fulvestrant in the extended phase, if they have received fulvestrant for breast cancer, they need to be excluded.
  • The first-line endocrine therapy was used in the late stage, and the drug was stopped for less than 4 weeks;
  • Have received radiotherapy within 4 weeks prior to study;
  • Have received chemotherapy for advanced breast cancer> 2 lines (the subjects who have used chemotherapy drugs must have stopped the chemotherapy drugs for ≥ 4 weeks before being enrolled in this study);
  • Patients with parenteral nutrition; malabsorption syndrome; or any condition possibly affecting drug absorption or inability to tolerate oral medications;
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  • 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;
  • Patients who are known to have a history of allergies to Hemay022, exemestane or similar drugs (Note: For patients who are planning to combine letrozole or fulvestrant, if they are known to be allergic to letrozole or fulvestrant History cannot be included in this study);
  • Left ventricular ejection fraction (LVEF) <50％ as measured by echocardiogram or MUGA scan;
  • Positive blood for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening;
  • Complicated with ≥2 grade diarrhea or ≥2 grade nausea condition;
  • Active infection (ie, requiring intravenous antibiotic or antiviral agent);
  • Uncontrolled hypertension (systolic blood pressure> 150 mmHg, diastolic blood pressure> 100 mmHg after antihypertensive treatment);
  • Significant heart diseases, including ischemic heart disease (NYHA III-IV), history of myocardial infarction or uncontrolled angina within 6 months, occurrence congestive heart failure within 3 months;
  • 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);
  • Confirmed ECG abnormalities, including QTc (heart rate corrected according to Bazett formula or Fridericia formula) prolongation (≥450msec), QRS> 120ms;
  • History of hemorrhagic or thrombus events within 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, spontaneous tumor bleeding;
  • Have received other clinical trial treatments or other targeted drugs within 4 weeks before the study;
  • Major surgery or injury less than 4 weeks before the study;
  • Other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except symptomatic local radiotherapy) during the research;
  • Any other malignant cancer within 5 years with the exception of adequately treated cervical cancer in situ or basal and squamous cutaneous cell carcinomas;
  • History of alcohol or drug abuse;
  • Serious psychogenic illness;
  • Evidence of significant medical illness or abnormal laboratory finding that would make the subject inappropriate for this study by the investigator's judgment;
  • Subjects could not complete the study due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated regimen). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with exemestane, and the safety of Hemay022 in combination with letrozole or fulvestrant.

The research will be divided into two parts. In the first part, 15 to 24 subjects will be enrolled to determine the safety and tolerability of combining Hemay022 with exemestane in patients with HER2-positive advanced breast cancer. The second part will enroll about 24-36 other subjects with ER and HER2-positive advanced breast cancer to better determine the tolerability and preliminary efficacy of Hemay022.

Conditions
Breast Cancer
Being tested
Hemay022+exemestane, Hemay022+letrozole, Hemay022+ fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemay022+exemestaneDrug

    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 combination with exemestane.

  • Hemay022+letrozoleDrug

    Part two: Hemay022 combination with letrozole.

  • Hemay022+ fulvestrantDrug

    Part two: Hemay022 combination with fulvestrant.

Study groups in NCT03308201
Study groupRoleWhat they receive
Hemay022 and ExemestaneExperimentalPart 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.
Receives: Drug: Hemay022+exemestane
Hemay022 and LetrozoleExperimentalPart two: Hemay022 in combination with letrozole will be taken in OTR dose until disease progression, intolerable toxicity or death.
Receives: Drug: Hemay022+letrozole
Hemay022 and FulvestrantExperimentalPart two: Hemay022 in combination with fulvestrant will be taken in OTR dose until disease progression, intolerable toxicity or death.
Receives: Drug: Hemay022+ fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Measured: from baseline until 4 weeks after the study day

Secondary outcomes (7)

  1. Objective response rate (complete response rate + partial response rate) according to RECIST v1.1

    Measured: 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

    Measured: 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)

    Measured: 18 months after treatment initiation

  4. Observed maximum concentration of Hemay022 and exemestane

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: pre-dose on day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start16 Oct 2017
  3. Primary completion30 Jun 2022
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308201
Sponsor's protocol ID
HM022BC1C01
Status last verified
Mar 2024
First submitted
29 Sep 2017
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hemay022+exemestane, Hemay022+letrozole and Hemay022+ fulvestrant in people with Breast Cancer, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: from baseline until 4 weeks after the study day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03308201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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