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Metastatic Breast CancerPhase 1/2NCT00912275

Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

A Phase 1/2 study testing lapatinib plus oral vinorelbine in people with Metastatic Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

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

Phase I part: to determine the recommended dose, and observe the preliminary response and safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
lapatinib plus oral vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTaiwan
Study dates
24 Nov 2008to 7 Jul 2017
Phase
Phase 1/2
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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the breast which is now metastatic.
  • Documented ErbB2 over expression or amplified disease in the invasive component of the primary or metastatic lesion as defined by:
  • 3+ over expression by IHC or
  • ErbB2 gene amplification by FISH/CISH (> 6 ErbB2 gene copies per nucleus, or a FISH ratio (ErbB2 gene copies to chromosome 17 signals) of > than 2.2;
  • In phase II part, patients must be chemo-naïve in metastatic setting. In phase I part, patient may have received prior chemotherapy including vinorelbine in metastatic setting. However, patient must be informed and well understand that in current standard of treatment, suggested first line treatments for erbB-2 positive, visceral organ metastatic breast cancer are combination of chemotherapy with herceptin.
  • In phase II part, patient must not have exposed to ant-erbB2 targeted therapy treatment in metastatic setting. Herceptin treatment in the neoadjuvant or adjuvant setting is permitted provide that at least 12 months has elapsed since the last dose of herceptin therapy. In phase I part, patient may have received prior anti-erbB-2 targeted treatment in metastatic setting.
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  • Prior treatment with endocrine therapy in the adjuvant or metastatic setting permitted provided that therapy has been discontinued.
  • Prior treatments with radiation therapy for palliative management of metastatic disease permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are < grade 1 at the time of registration.
  • Patients must have evidence of metastatic disease, but measurable disease is not mandatory. To be considered evaluable for the overall response rate (complete and partial response), patients must have at least one measurable lesion as follows:
  • X-ray, physical exam >= 20 mm
  • Conventional CT scan, MRI >= 20 mm
  • Spiral CT scan >= 10 mm
  • Age > 20 years.
  • Life expectancy > 3 months.
  • ECOG PS 0-2.
  • Patients must have normal organ and marrow function measured within 14 days prior to randomization as defined below:
  • Hemoglobin>10.0;
  • Absolute neutrophil count > 1,500/uL;
  • Platelets >75,000/uL;
  • Total bilirubin <= 1.5 X upper normal limit;
  • AST(SGOT)/ALT(SGPT) <= 2.5 X upper normal limit;
  • Creatinin <= 1.5 X upper normal limit;
  • Patient must have cardiac ejection fraction > 50% and within the institutional range of normal as demonstrated by MUGA scan/echocardiogram within 4 weeks of registration.
  • CT or MRI within 4 weeks prior to randomization.
  • Women of childbearing potential must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration.
  • Patient consent must be obtained.

Who cannot join

  • Pregnant or lactating women.
  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Prior therapy with lapatinib.
  • CNS metastases.
  • Ongoing anticancer treatment.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious non-healing wound/ulcer/bone fracture, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Oncology,National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Phase I/II Study of Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

Phase I part: to determine the recommended dose, and observe the preliminary response and safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer.

Phase II part: to determine the progression free survival, response rate, and to evaluate the safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer.

Phase I part has been completed. Phase II part is underway.

Read the detailed description

This is a phase I/II clinical trial. In phase I part, the primary objective is To determine the recommended dose of the combination of lapatinib with oral vinorelbine in patients with ErbB2 positive metastatic breast cancer. In phase II part, the primary objective is progression free survival of the combination of lapatinib with oral vinorelbine as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. The secondary objectives are safety profile and the response rate

Lapatinib, an oral inhibitor of EGFR and HER2, have been shown to be an effective treatment in HER2/neu overexpressing metastatic breast cancer patient who refractory herceptin, taxane, and anthracycline treatment. In pre-clinical studies, the highest synergism between anti-Her2 treatment (trastuzumab) and cytotoxics was seen with the platinum compounds and with vinorelbine. The oral vinorelbine has similar efficacy to that of the injection formulation and has demonstrated generally favorable tolerability. We are interested in lapatinib plus oral vinorelbine as 1st line treatment in Her2+ MBC, to which we believe this convenience treatment offer a good response rate with satisfactory life quality.

For phase I part, we plan to use the standard phase I 3-patient cohort (''3 + 3'') design. Up to 18 patients may be enrolled. For phase II part, the expected progression-free survival of the protocol treatment in first line treatment of ErbB2 positive metastatic breast cancer is more than 6 months. With type 1 and type 2 errors of 0.05 and 0.1, respectively, this design calls for 29 patients at the first stage. If 20 or more progression disease is observed after 6 months of treatment, then the study will be terminated. Otherwise, additional 25 patients will be entered at the second stage. The treatment will be rejected if a total of 37 or more progression disease are observed out of 54 patients after 6 months of treatment. With the estimated dropout rate of 10%, 32 patients will be accrued in the first stage and 28 in the second stage.

Being tested
lapatinib plus oral vinorelbine
Medical subject headings
Breast Neoplasms

What participants receive

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

  • lapatinib plus oral vinorelbineDrug

    Also called Tykerb, Navelbine

    Lapatinib -dose level -I, I, II, III 1000mg po daily;dose level IV:1250mg po daily; Oral vinorelbine at the dose level reached on days 1, and 8 of a 21 days cycle. Dose level -I:30mg/m2,I:40mg/m2,II:50mg/m2,III:60mg/m2,IV:60mg/m2,V:80mg/m2

Study groups in NCT00912275
Study groupRoleWhat they receive
Lapatinib plus Oral VinorelbineExperimentalOral vinorelbine on day 1 and day 8 q3w plus lapatinib 1000mg/day.
Receives: Drug: lapatinib plus oral vinorelbine

What is being measured

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

  1. To determine the recommended dose of the combination of oral lapatinib with vinorelbine (phase I part), and progression free survival (phase II part)

    Measured: phase I part: 4 months, phase II part: 1 and half years

Secondary outcomes (1)

  1. response rate, safety profile

    Measured: 2 years

Timeline

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

  1. First posted3 Jun 2009 (estimated)
  2. Study start24 Nov 2008
  3. Primary completion31 Mar 2015
  4. Study completion7 Jul 2017

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00912275
Sponsor's protocol ID
200811019M
Status last verified
May 2019
First submitted
1 Jun 2009
Last updated
6 May 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lapatinib plus oral vinorelbine in people with Metastatic Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

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 26 inclusion and 7 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 May 2019. 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 Taiwan. 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 combined 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.

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 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?

To determine the recommended dose of the combination of oral lapatinib with vinorelbine (phase I part), and progression free survival (phase II part) (time frame: phase I part: 4 months, phase II part: 1 and half years). 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 NCT00912275.

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 May 2019.

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