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Breast CancerPhase 2NCT04066790

Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

A Phase 2 study testing Pyrotinib, nab-Paclitaxel and Trastuzumab in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
Pyrotinib, nab-Paclitaxel and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
9 Sep 2019to 30 Apr 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • With signed consent
  • Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique
  • Breast cancer stage at presentation: stage I-III
  • HER2-positive breast cancer defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization
  • Known hormone receptor status (estrogen receptor and/or progesterone receptor)
  • Eastern Cooperative Oncology Group Performance Status equal to or less than (<=) 1
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  • Baseline left ventricular ejection fracture >= 50% measured by echocardiography
  • Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male
  • Negative serum pregnancy test for women with fertility
  • Willing to obey the study protocol

Who cannot join

  • Stage IV disease
  • Previous anti-cancer therapy or radiotherapy for any malignancy
  • History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
  • Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy
  • Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered
  • Serious cardiac illness or medical condition
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  • Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
  • Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization
  • Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
  • Not able to swallow the drug
  • Pregnant or lactating

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer

This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

Read the detailed description

The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with nab-paclitaxel or 4 cycles of trastuzumab with nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive 4 cycles of epirubicin in combination with cyclophosphamide, then complete 1 year of trastuzumab.

Conditions
Breast Cancer
Being tested
Pyrotinib, nab-Paclitaxel, Trastuzumab, EC chemotherapy, Surgery
Keywords
HER2-positive, neoadjuvant
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PyrotinibDrug

    Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.

  • nab-PaclitaxelDrug

    Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.

  • TrastuzumabDrug

    Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose for Cycle 9, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab

  • EC chemotherapyDrug

    epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks 4 cycles (Cycles 5-8)

  • SurgeryProcedure or surgery

    All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Study groups in NCT04066790
Study groupRoleWhat they receive
Pyrotinib in combination with nab-paclitaxelExperimentalPrior to surgery: pyrotinib and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.
Receives: Drug: Pyrotinib; Drug: nab-Paclitaxel; Drug: Trastuzumab; Drug: EC chemotherapy; Procedure: Surgery
Trastuzumab in combination with nab-paclitaxelActive comparatorPrior to surgery: trastuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.
Receives: Drug: nab-Paclitaxel; Drug: Trastuzumab; Drug: EC chemotherapy; Procedure: Surgery

What is being measured

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

  1. Percentage of Participants With Total Pathologic Complete Response (tpCR)

    tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).The duration of one treatment cycle is 21 days.

    Measured: Cycle 4 . The duration of one treatment cycle is 21 days.

Secondary outcomes (5)

  1. Percentage of Participants With Breast Pathologic Complete Response (bpCR)

    bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system).The duration of one treatment cycle is 21 days.

    Measured: Cycle 4 . The duration of one treatment cycle is 21 days.

  2. Clinical response

    Percentage of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The duration of one treatment cycle is 21 days.

    Measured: Cycle 4 . The duration of one treatment cycle is 21 days.

  3. Event-free survival (EFS)

    EFS is defined as the time from randomization to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST v1.1 Any evidence of contralateral disease in situ was not identified as progressive disease; Disease recurrence (local, regional, distant, or contralateral) after surgery; Death from any cause.

    Measured: From Baseline to EFS event or date last known to be alive and event-free (up to 5 years)

  4. Disease-free survival (DFS)

    DFS was defined as the time from first date of no disease (i.e., date of surgery) to first documentation of one of the following events: Disease recurrence (local, regional, distant, or contralateral) after surgery. Any evidence of contralateral disease in situ was not identified as disease recurrence; Death from any cause.

    Measured: From surgery to DFS event or date last known to be alive and event-free (up to 5 years)

  5. Overall survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: From Baseline to OS event or date last known to be alive (up to 5 years)

Timeline

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

  1. First posted26 Aug 2019
  2. Study start9 Sep 2019
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Why it stopped: We terminated this trial and initiated a new one including pertuzumab.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066790
Sponsor's protocol ID
RJBC1901
Status last verified
May 2020
First submitted
19 Aug 2019
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib, nab-Paclitaxel and Trastuzumab in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 May 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 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?

The study was stopped early (reason given: We terminated this trial and initiated a new one including pertuzumab.). 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?

Percentage of Participants With Total Pathologic Complete Response (tpCR) (time frame: Cycle 4 . The duration of one treatment cycle is 21 days.). 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 NCT04066790.

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 19 May 2020.

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