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Metastatic Breast CancerPhase 2NCT04407988

Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer

A Phase 2 study testing Pyrotinib Maleate plus Letrozole in people with Metastatic Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, single-arm, multi-center clinical study of pyrotinib in combination With letrozole in patients With HER2-Positive, ER-Positive metastatic breast cancer. Our aim was to explore the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive, ER-positive metastatic… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Pyrotinib Maleate plus Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteChina
Study dates
6 Nov 2019to 31 Mar 2023
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with HER2+/ER+ recurrent or metastatic breast cancer confirmed by histopathology;
  • HER2 positive: HER2 IHC 3+, or HER2 IHC 2+ and ISH positive
  • ER positive: the percentage of cells positive for ER expression ≥ 10%
  • Premenopausal, perimenopausal or postmenopausal patients (with OFS, if pre- or perimenopausal);
  • If the patient is bilateral breast cancer, metastasis lesions must be HER2 and ER positive;
  • 18-70 years old;
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  • ECOG PS 0～1;
  • Life expectancy is not less than 12 weeks;
  • At least one measurable lesion according to RECIST 1.1;
  • Prior (neo) adjuvant trastuzumab, pertuzumab or chemotherapy were eligible, and the disease free interval must be greater than 12 months from completion of (neo) adjuvant trastuzumab and pertuzumab to metastatic diagnosis;
  • Prior (neo) adjuvant hormone therapy was allowed, if received adjuvant AI, the disease free interval must be greater than 12 months from the completion of treatment;
  • Disease-free Survival after surgery (DFS) ≥12 months;
  • Patients with adequate organ function before enrollment: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, Hb ≥ 100 g/L; TBIL≤1.0ULN；ALT and AST≤3×ULN (ALT and AST≤5×ULN if liver metastasis); BUN and Cr≤1.5×ULN and CCr≥50 mL/min; LVEF ≥ 50% and QTc < 480 ms;
  • Signed informed consent.

Who cannot join

  • Central nervous system metastasis;
  • patients with Visceral crisis;
  • Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
  • received radiotherapy, hormone therapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy for advanced or metastatic disease;
  • received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks prior to randomization;
  • Received hormone therapy within 2 weeks prior to randomization;
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  • Participated in other clinical trial within 4 weeks prior to randomization;
  • Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors (lapatinib, neratinib or pyrotinib);
  • Other malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
  • Receive other anti-tumour therapy at the same time;
  • History of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known;
  • History of any kind of Heart disease;
  • All female patients in pregnancy or breastfeeding period, fertile women with positive baseline pregnancy tests;
  • Evidence of significant medical illness that will substantially increase the risk on the participation or completion of the study in the investigator's judgment. Examples included, but not limited to, hypertension, severe diabetes, etc;
  • History of neurological or psychiatric disorders, including epilepsy or dementia;
  • Patients not eligible for this study judged by the investigator.

Trial locations and contacts

1 site in 1 country.

Quchang Ouyang, PhD contact

+86 13973135318

Oyqc1969@126.com

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

    Quchang Ouyang, PhD, +86 13973135318, Oyqc1969@126.com

    Quchang Ouyang, PhD

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer

This is a prospective, single-arm, multi-center clinical study of pyrotinib in combination With letrozole in patients With HER2-Positive, ER-Positive metastatic breast cancer. Our aim was to explore the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive, ER-positive metastatic breast cancer.

Read the detailed description

ER+/HER2+ metastatic breast cancer is a special subtype of HER2+ breast cancer. General guidelines recommend chemotherapy combined with HER2-targeted therapy for this subtype of patients. However, for the highly selected patients with ER- positive/HER2-positive ABC, ET + anti-HER2 therapy could be chosen as first-line therapy. And Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Therefore this study is planned to enroll 86 patients with HER2-positive, ER-positive metastatic breast cancer receiving first-line treatment with pyrotinib and letrozole. The main purpose was to evaluate the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive, ER-positive metastatic breast cancer.

Being tested
Pyrotinib Maleate plus Letrozole
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Pyrotinib Maleate plus LetrozoleDrug

    pyrotinib(400 mg once daily) + Letrozole (2.5 mg once daily)

Study groups in NCT04407988
Study groupRoleWhat they receive
Pyrotinib plus LetrozoleExperimentalNot described
Receives: Drug: Pyrotinib Maleate plus Letrozole

What is being measured

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

  1. Clinical Benefit rate (CBR)

    Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects

    Measured: Estimated 12 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Ratio of CR and PR in all subjects

    Measured: Estimated 12 months

  2. Progression Free Survival (PFS)

    From enrollment to progression or death (for any reason

    Measured: Estimated 12 months

  3. Overall Survival (OS)

    From enrollment to death (for any reason)

    Measured: Estimated 24 months

  4. Adverse Events and Serious Adverse Events

    Adverse events are described in terms of CTC AE 4.0

    Measured: From informed consent through 28 days following treatment completion

Timeline

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

  1. First posted29 May 2020
  2. Study start6 Nov 2019
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Mar 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pyrotinib plus Letrozole
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407988
Sponsor's protocol ID
HR-BLTN-008
Status last verified
Oct 2021
First submitted
25 May 2020
Last updated
13 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hu ZY, Yan M, Xiong H, Ran L, Zhong J, Luo T, Sun T, Xie N, Liu L, Yang X, Xiao H, Li J, Liu B, Ouyang Q. Pyrotinib in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer (PLEHERM): a multicenter, single-arm, phase II trial. BMC Med. 2023 Jun 26;21(1):226. doi: 10.1186/s12916-023-02943-2.

    PubMed 37365596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib Maleate plus Letrozole in people with Metastatic Breast Cancer, run by Hunan Cancer Hospital 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 16 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Quchang Ouyang, PhD (+86 13973135318, Oyqc1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit rate (CBR) (time frame: Estimated 12 months). 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 NCT04407988, which also lists 1 linked publication.

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 13 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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