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Breast CancerPhase 2NCT00943410

Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer

A Phase 2 study testing external beam radiation therapy and Herceptin in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center.

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, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
external beam radiation therapy and Herceptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
No sites listed yet
Study dates
Mar 2000to Jul 2009
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed* invasive primary carcinoma of the breast by fine-needle aspiration, core needle biopsy, or incisional biopsy
  • Excisional biopsy is not allowed
  • Stage III or IV disease (clinical and radiographic staging), including any of the following:
  • Any T with N2 disease (metastasis to ipsilateral axillary lymph nodes fixed to one another or other structures) or N3 disease (metastasis to ipsilateral internal mammary lymph nodes)
  • T4, any N disease
  • Inflammatory disease
  • Supraclavicular and/or infraclavicular adenopathy
  • Distant metastasis with measurable disease in the breast or lymph nodes
  • HER2-overexpressing tumor
  • Measurable or evaluable disease
  • Residual locoregional disease after completion of neoadjuvant chemotherapy OR locoregional recurrent disease
  • Synchronous bilateral primary cancers allowed provided the more serious of the two cancers meets staging criteria
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • WBC > 2,000/mm^3
  • Platelet count > 50,000/mm^3
  • Hemoglobin > 11 g/dL
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Radionucleotide ventriculography/LVEF normal OR ≤ 10% asymptomatic decline from baseline after completion of neoadjuvant chemotherapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to the breast or regional lymph nodes
  • Concurrent participation in neoadjuvant chemotherapy clinical trials allowed

About this study

Official title: Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer

RATIONALE: Monoclonal antibodies, such as trastuzumab, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Trastuzumab may make tumor cells more sensitive to radiation therapy. Giving trastuzumab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving trastuzumab together with external beam radiation therapy works in treating women with stage III or stage IV breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam radiotherapy in women with HER2-overexpressing stage III or IV breast cancer.

Secondary

  • Determine the pathologic response rate in patients treated with this regimen.
  • Determine the locoregional recurrence rate (as site of first recurrence or any recurrence) and time to locoregional recurrence in patients treated with this regimen.
  • Determine the time to local progression in patients (who are deemed to be non-surgical candidates) treated with this regimen .

OUTLINE: This is a multicenter study.

Patients receive trastuzumab IV over 30-90 minutes once a week for 5 weeks. Patients also undergo external beam radiotherapy once daily 5 days a week for 5 weeks.

Three weeks after the completion of trastuzumab and radiotherapy, patients undergo surgical evaluation. Patients deemed to be surgical candidates undergo surgery. Patients deemed to be non-surgical candidates continue to receive trastuzumab and external beam radiotherapy for 2 additional weeks.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions
Breast Cancer
Being tested
external beam radiation therapy, Herceptin
Keywords
HER2-positive breast cancer, inflammatory breast cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

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

  • external beam radiation therapyRadiation

    Radiation therapy will consist of 50Gy in 2Gy fractions to the breast/chest wall and regional lymphatics for 5 consecutive days up to 5 weeks for surgical candidates and 7 weeks for non-surgical candidates

  • HerceptinDrug

    Patients who are already receiving weekly Herceptin® will continue weekly Herceptin®, 2mg/kg IV on day 1 of each week of radiotherapy. Patients who have not been receiving weekly Herceptin® as a component of systemic therapy will begin Herceptin® one week prior to beginning radiotherapy with a loading dose of 4mg/kg followed by weekly Herceptin® at 2mg/kg on day 1 of each week of radiotherapy

Study groups in NCT00943410
Study groupRoleWhat they receive
Surgical CandidateActive comparatorAfter 5 consecutive weeks of treatment with Radiation and Herceptin, these subjects will receive mastectomy excision
Receives: Radiation: external beam radiation therapy; Drug: Herceptin
Non-Surgical CandidateActive comparatorAfter 5 weeks of consecutive treatment with radiation and herceptin, these subjects will not be eligible for surgery. They will continue with radiation and herceptin for an additional 2 weeks.
Receives: Radiation: external beam radiation therapy; Drug: Herceptin

What is being measured

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

  1. Number of subjects experiencing adverse events

    Toxicity (adverse events) will be measured and graded using the CTCAE criteria. RTOG acute toxicity criteria will be used to score acute radiation-related toxicity

    Measured: 7 weeks

Secondary outcomes (4)

  1. Pathologic response rate

    Pathological response will be measured for those subjects who are deemed surgical candidates. Pathologic response will be defined as invasive tumor present pathologically, or complete invasive tumor clearance (pCR), which includes those tumors with no tumor present as well as those tumors with only in situ carcinoma present after all therapy

    Measured: 5 weeks

  2. Locoregional recurrence rate

    Radiographic response and recurrence rate will captured using RECIST criteria. Subjects will be followed up for 5 years to document recurrence.

    Measured: up to 5 years

  3. Time to locoregional recurrence

    Radiographic response and recurrence rate will captured using RECIST criteria. Subjects will be followed up to 5 years to document recurrence

    Measured: Up to 5 years

  4. Time to local progression (in patients who are deemed to be non-surgical candidates)

    Radiographic response and recurrence rate will captured using RECIST criteria. Disease progression is defined as an increase in the product of two perpendicular diameters of any measured lesion by > 25% over the size at study entry or the appearance of new areas of malignant disease

    Measured: 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 posted22 Jul 2009 (estimated)
  2. Study startMar 2000
  3. Primary completionJan 2006
  4. Study completionJul 2009

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00943410
Sponsor's protocol ID
LCCC 9925
Other IDs
CDR000649128
Status last verified
Aug 2012
First submitted
21 Jul 2009
Last updated
15 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing external beam radiation therapy and Herceptin in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center.

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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of subjects experiencing adverse events (time frame: 7 weeks). 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 NCT00943410.

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 15 Aug 2012.

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