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HER2 Positive Metastatic Breast CancerPhase 3NCT03080805

Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)

A Phase 3 study testing Pyrotinib Plus Capecitabine and Lapatinib Plus Capecitabine in people with HER2 Positive Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HER2 Positive Metastatic Breast Cancer
What is being tested?
Pyrotinib Plus Capecitabine and Lapatinib Plus Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
3 May 2017to Mar 2021
Phase
Phase 3
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

  • Aged ≥18 and ≤70 years.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • According to RECIST 1.1, at least one measurable lesion exists
  • Histologically or cytologic confirmed HER2 positive metastatic breast cancer.
  • Prior treatment with trastuzumab (≥2 cycles in metastatic setting, or
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  • ≥3 months in adjuvant/neoadjuvant setting) and Taxane(≥2 cycles in any setting or untill unendurable AE or progression during treatment).
  • Previously reveived ≤2 chemotherapy regimens in metastasis setting;
  • Required laboratory values including following parameters:
  • ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2 x ULN(patients with liver metastases: ≤5 x ULN); BUN and Creatinine:
  • ≤ 1x ULN;CCR≥50 mL/min;LVEF: ≥ 50%;QTcF: < 450 ms (male)，< 470 ms（female）;
  • Signed informed consent.

Who cannot join

  • Received capecitabine in metastatic setting;
  • Received HER2 targeted tyrosine kinase inhibitor (including Lapatinib, Neratinib and Pyrotinib);
  • Cumulated dosage of Doxorubincin >400 mg/m^2 or Epirubicin >800 mg/m^2 or equal dosage of other anthracycline drugs in adjuvant/neoadjuvant/metastatic setting );
  • Received surgery，chemotherapy,radiotherapy or target therapy within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization;
  • Participated in other clinical trial within 28 days prior to randomization.
  • Known dihydro pyrimidine dehydrogenase（DPD）defect;
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  • CT or MRI confirmed brain metastases;
  • Bone or skin lesion as unique target lesion;
  • Second malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
  • Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
  • Uncontrolled third space effusion (such as pleural fluid and ascites) by drainage or other clinical intervention;
  • Receiving any other anti-tumour therapy after informed consent;
  • Unprogressed after or during the last anti-tumour therapy,according to RECIST1.1;
  • History of any kind of Heart disease,including 1)Angina pectoris; (2) Arrhythmia required medication or with clinical significance; (3) Myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by researcher as not suitable for participating in this study, etc;
  • History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation;
  • History of neurological or psychiatric disorders, including epilepsy or dementia;
  • Concomitant disease judged by investigators that may bring serious harm to the safety of patients or the completion of this study;
  • All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study;
  • Any other situations judged by investigator as not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital,Chinese Academy of Medical Science

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1 ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily).Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawalof consent.

Being tested
Pyrotinib Plus Capecitabine, Lapatinib Plus Capecitabine

What participants receive

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

  • Pyrotinib Plus CapecitabineDrug

    pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/ m^2 BID)

  • Lapatinib Plus CapecitabineDrug

    Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)

Study groups in NCT03080805
Study groupRoleWhat they receive
Pyrotinib Plus CapecitabineExperimentalNot described
Receives: Drug: Pyrotinib Plus Capecitabine
Lapatinib Plus CapecitabineActive comparatorNot described
Receives: Drug: Lapatinib Plus Capecitabine

What is being measured

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

  1. Progression Free Survival(PFS)

    From infromed consent to progression or death

    Measured: Estimated 10 months

Secondary outcomes (6)

  1. Safety: AE

    AE

    Measured: AE recorded from infromed consent to 28 days after treatment completion

  2. Overall Survival (OS)

    From infromed consent to death

    Measured: Estimated 30 months

  3. Objective Response Rate (ORR)

    CR+PR

    Measured: Estimated 10 months

  4. Time to Progression (TTP)

    From infromed consent to progression

    Measured: Estimated 10 months

  5. Duration of Response (DOR)

    CR+PR+SD

    Measured: Estimated 10 months

  6. Clinical Benefit rate (CBR)

    CR+PR+SD≥24 weeks

    Measured: Estimated 10 months

Timeline

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

  1. First posted15 Mar 2017
  2. Study start3 May 2017
  3. Primary completion31 Mar 2019
  4. Study completionMar 2021 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080805
Sponsor's protocol ID
HR-BLTN-Ⅲ-MBC
Status last verified
Jun 2020
First submitted
3 Mar 2017
Last updated
18 Jun 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bao Y, Zhang Z, He X, Cai L, Wang X, Li X. Cost-Effectiveness of Pyrotinib Plus Capecitabine versus Lapatinib Plus Capecitabine for the Treatment of HER2-Positive Metastatic Breast Cancer in China: A Scenario Analysis of Health Insurance Coverage. Curr Oncol. 2022 Aug 23;29(9):6053-6067. doi: 10.3390/curroncol29090476.

    PubMed 36135045

  • Xu B, Yan M, Ma F, Hu X, Feng J, Ouyang Q, Tong Z, Li H, Zhang Q, Sun T, Wang X, Yin Y, Cheng Y, Li W, Gu Y, Chen Q, Liu J, Cheng J, Geng C, Qin S, Wang S, Lu J, Shen K, Liu Q, Wang X, Wang H, Luo T, Yang J, Wu Y, Yu Z, Zhu X, Chen C, Zou J; PHOEBE Investigators. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Mar;22(3):351-360. doi: 10.1016/S1470-2045(20)30702-6. Epub 2021 Feb 11.

    PubMed 33581774

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pyrotinib Plus Capecitabine and Lapatinib Plus Capecitabine in people with HER2 Positive Metastatic Breast Cancer, run by Jiangsu HengRui Medicine 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 12 inclusion and 19 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 18 Jun 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Progression Free Survival(PFS) (time frame: Estimated 10 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 NCT03080805, which also lists 2 linked publications.

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 18 Jun 2020.

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