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Breast CancerPhase 2NCT00301899

Trastuzumab and Pertuzumab in Treating Patients With Unresectable Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Trastuzumab

A Phase 2 study testing pertuzumab and trastuzumab in people with Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

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

RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
pertuzumab and trastuzumab
How many people
37 participants
Where
1 siteUnited States
Study dates
Dec 2005to Oct 2007
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer of 1 of the following stages:
  • Metastatic disease (stage IV)
  • Inoperable locally advanced disease
  • Disease progression after prior neoadjuvant chemotherapy required
  • Disease progression on or after trastuzumab (Herceptin®) based-therapy
  • Received 1-3 prior trastuzumab-based regimens
  • HER2/neu-positive tumor, defined as 3+ by fluorescent in situ hybridization
  • Measurable disease, defined as at least 1 lesion that can be measured in at least one dimension
  • No clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT scan or MRI
  • Brain and/or leptomeningeal metastases allowed if patient has stable lesions after standard treatment (surgery or radiotherapy), is asymptomatic on neurological exam, and is not receiving corticosteroid therapy to control symptoms
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Male or female
  • Menopausal status not specified
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase < 5 times ULN
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • LVEF above lower limit of normal by echocardiogram or MRI
  • No clinical signs or symptoms of heart failure
  • No uncontrolled hypertension (i.e., blood pressure ≥ 180/100 mm Hg)
  • No significant valvular disease (i.e., aortic or mitral regurgitation of 3 or 4+/4+ severity or stenosis of either valve)
  • No history of uncontrolled cardiac arrhythmia
  • No symptomatic or asymptomatic myocardial infarction
  • No angina pectoris requiring medication
  • No other documented significant cardiac event
  • No poorly controlled diabetes mellitus (i.e., fasting blood sugar ≥ 200 mg/dL)
  • No history of hypersensitivity reaction to trastuzumab
  • No AIDS
  • No nonmalignant condition requiring ≥ 20 mg of prednisone (or equivalent)
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No ongoing liver disease, including viral or other hepatitis, alcohol abuse, or cirrhosis
  • No other serious medical illness
  • No medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • More than 3 weeks since prior investigational anticancer agents
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), major surgery, or immunotherapy
  • More than 4 weeks since prior radiotherapy except short-course palliative radiotherapy for bone pain
  • More than 2 weeks since prior and no concurrent oral hormonal therapy
  • More than 4 weeks since prior fulvestrant
  • No prior doxorubicin hydrochloride or doxorubicin HCl liposome at a cumulative dose of > 360 mg/m^2
  • No prior mitoxantrone hydrochloride at a cumulative dose of > 120 mg/m^2
  • No prior epirubicin hydrochloride at a cumulative dose of > 600 mg/m^2
  • No prior idarubicin at a cumulative dose of > 90 mg/m^2
  • No concurrent radiation therapy, including for symptomatic bone metastases

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Safety Using Combined Monoclonal Antibodies, Trastuzumab and Pertuzumab in Subjects With Her-2 Overexpressed Locally Advanced and Metastatic Breast Cancer

RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving trastuzumab together with pertuzumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with pertuzumab works in treating patients with unresectable locally advanced or metastatic breast cancer that did not respond to previous trastuzumab.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with HER2/neu-overexpressing, inoperable locally advanced or metastatic breast cancer refractory to trastuzumab (Herceptin®)-based therapy treated with trastuzumab and pertuzumab.
  • Determine the safety and tolerability of this regimen in these patients.

Secondary

  • Determine the time to progression, progression-free survival, duration of response, and the percentage of patients free from disease progression at 3, 6, and 12 months.
  • Correlate pre-treatment HER-2/neu phosphorylation and the phosphorylation of downstream markers of signaling pathways using tumor tissue and blood with pertuzumab sensitivity and/or trastuzumab resistance in these patients.

OUTLINE: This is an open-label study.

Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1 and pertuzumab IV over 30-60 minutes on day 2 of course 1. Beginning in course 2 and for all subsequent courses, patients receive both trastuzumab and pertuzumab on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
pertuzumab, trastuzumab
Keywords
recurrent breast cancer, male breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

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

What is being measured

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

  1. Safety

  2. Minimal rate of clinical responses

Secondary outcomes (4)
  1. Time to progression

  2. Time to response

  3. Response duration

  4. Progression-free survival

Timeline

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

  1. First posted13 Mar 2006 (estimated)
  2. Study startDec 2005
  3. Study completionOct 2007

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
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301899
Sponsor's protocol ID
060035
Other IDs
06-C-0035, NCI-P6660, CDR0000462639
Status last verified
Mar 2012
First submitted
9 Mar 2006
Last updated
8 Mar 2012
Results posted
No

Publications

  • Baselga J, Gelmon KA, Verma S, Wardley A, Conte P, Miles D, Bianchi G, Cortes J, McNally VA, Ross GA, Fumoleau P, Gianni L. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J Clin Oncol. 2010 Mar 1;28(7):1138-44. doi: 10.1200/JCO.2009.24.2024. Epub 2010 Feb 1.

    PubMed 20124182

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pertuzumab and trastuzumab in people with Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site 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?

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 8 Mar 2012. 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 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?

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?

Safety. The study lists 2 primary outcomes in all. 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 NCT00301899, 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 8 Mar 2012.

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Clinical Trial NCT00301899 | AzTrials