AzTrials
AzTrials

Neoplasms, BreastPhase 2NCT00444535

Lapatinib and Bevacizumab for Metastatic Breast Cancer

A Phase 2 study testing lapatinib and bevacizumab in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 9 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
lapatinib and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
9 sitesUnited States
Study dates
27 Feb 2007to 19 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Females that are at least 18 years of age.
  • Women of childbearing potential must have a negative serum pregnancy test at screening.
  • Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.
  • Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.
  • Adequate hepatic, renal and cardiac function
  • ECOG score 0-1 and a life expectancy of at least 12 weeks.
  • Able to swallow oral medication
  • Signed informed consent

Who cannot join

  • Pregnancy
  • Unstable or symptomatic CNS metastases
  • Major surgery within 28 days of enrollment (minor surgery within 7 days).
  • Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.
  • A serious non-healing wound, ulcer, or bone fracture at baseline.
  • Class II, III or IV heart failure as defined by the NYHA functional classification system
Show all 16Show fewer
  • History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.
  • History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.
  • History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
  • History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.
  • Proteinuria
  • Requires concurrent anti-cancer treatment or investigational treatment.
  • Known hypersensitivity to either study medication
  • Received investigational treatment within 28 days or 5 half-lives, whichever is longer
  • Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study
  • Requires medication that has been excluded during study participation

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Novartis Investigative Site

    Basking Ridge, New York, 07920

  • Novartis Investigative Site

    Commack, New York, 11725

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    New York, New York, 10065

  • Novartis Investigative Site

    Rockville Centre, New York, 11570

  • Novartis Investigative Site

    San Francisco, California, 94115

  • Novartis Investigative Site

    Sleepy Hollow, New York, 10591

  • Novartis Investigative Site

    Tampa, Florida, 33612

  • Novartis Investigative Site

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination With Bevacizumab in Subjects With Advanced or Metastatic ErbB2-Overexpressing Breast Cancer

This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.

Being tested
lapatinib, bevacizumab
Keywords
VEGF, Tyrosine kinase, ErbB2, Her2-neu, metastatic breast cancer, EGFR, ErbB1, bevacizumab, lapatinib, breast carcinoma, breast cancer, breast lump, breast cancer positive for human epidermal growth factor receptor 2 (HER2), HER2 positive metastatic breast cancer, breast cancer progression, estrogen-receptor (ER) positive(+) breast cancer, Paget's disease
Medical subject headings
Breast Neoplasms, Osteitis Deformans

What participants receive

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

  • lapatinibDrug

    Also called Tykerb/Tyverb

    1500 mg oral lapatinib (once daily)

  • bevacizumabDrug

    10 mg/kg intravenous bevacizumab (every two weeks)

Study groups in NCT00444535
Study groupRoleWhat they receive
Oral lapatinib tablets in combination with IV bevacizumabExperimental1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
Receives: Drug: lapatinib; Drug: bevacizumab

What is being measured

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

  1. Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment

    The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Since there is no independent reviewer, only the investigator response was reported.

    Measured: up to week 12

Secondary outcomes (6)

  1. Overall Tumor Response - Best Response Per Investigator Assessment (RECIST)

    Overall Tumor Response - Best Response per Investigator Assessment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by image including CT, MRI or bone scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    For each subject, the best tumor response during the study was considered to be the 'Overall Tumor Response' per the Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

  2. Overall Tumor Response Rate Per Investigator Assessment (RECIST)

    Overall Tumor Response Rate is defined as the percentage of subjects achieving either a confirmed complete (CR) or partial (PR) tumor response by investigator and per the Response Evaluation Criteria in Solid Tumors (RECIST). For each subject, the best tumor response during the study are considered the 'Overall Tumor Response.' Subjects with unknown or missing response are treated as non-responders; i.e. they are included in the denominator when calculating the percentage.

    Measured: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

  3. Investigator-Assessed Clinical Benefit Response Rate (%) (RECIST)

    Clinical Benefit Rate is defined as the percentage of subjects with evidence of confirmed complete or partial tumor responses at any time or stable disease for at least 24 weeks per the Response Evaluation Criteria in Solid Tumors (RECIST). Subjects with unknown or missing response are treated as non-responders (i.e. not Complete response (CR), Partial response (PR) or Stable Disease (SD)).

    Measured: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

  4. Progression-free Survival

    Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.

    Measured: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

  5. Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - Median

    Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve.

    Measured: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

  6. Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile

    Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve.

    Measured: This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.

Timeline

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

  1. First posted8 Mar 2007 (estimated)
  2. Study start27 Feb 2007
  3. Primary completion22 Jul 2008
  4. Study completion19 Jun 2020

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
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00444535
Sponsor's protocol ID
EGF103890
Other IDs
CLAP016A2201
Status last verified
Sep 2021
First submitted
6 Mar 2007
Last updated
25 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Publications

  • Rugo HS, Chien AJ, Franco SX, Stopeck AT, Glencer A, Lahiri S, Arbushites MC, Scott J, Park JW, Hudis C, Nulsen B, Dickler MN. A phase II study of lapatinib and bevacizumab as treatment for HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):13-20. doi: 10.1007/s10549-011-1918-z. Epub 2011 Dec 24.

    PubMed 22198412

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib and bevacizumab in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 9 sites in United States.

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 8 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: finished, as of the sponsor's last update on 25 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 9 sites in United States. 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?

Yes. Results are posted in the registry (first posted 20 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment (time frame: up to week 12). 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 NCT00444535, 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 25 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in