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Breast CancerPhase 2NCT00118053

Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

A Phase 2 study testing herceptin, carboplatin and docetaxel in people with Breast Cancer, run by University of Medicine and Dentistry of New Jersey at 9 sites in United States.

Terminated

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

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. 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?
herceptin, carboplatin and docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
9 sitesUnited States
Study dates
Apr 2005to Dec 2008
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
  • Stage IIB (T3, N0)
  • Stage IIIA (N0-N2)
  • Stage IIIB (T4, N0-2)
  • Stage IIIC
  • Inflammatory breast cancer
  • HER2/neu-positive disease by fluorescence in situ hybridization
  • Biopsy-accessible tumor
  • Measurable disease by physical examination or x-ray
  • No stage IV disease
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 8 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Meets 1 of the following criteria:
  • SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
  • SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
  • SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN
  • Bilirubin normal

Renal

  • Creatinine normal
  • No pre-existing clinically significant renal disease that is not related to the malignancy

Cardiovascular

  • Ejection fraction ≥ 50% by MUGA
  • No pre-existing clinically significant cardiac disease that is not related to the malignancy
  • No history of congestive heart failure

Pulmonary

  • No pre-existing clinically significant pulmonary disease that is not related to the malignancy

Gastrointestinal

  • No severe malnutrition
  • No intractable emesis

Neurologic

  • No pre-existing clinically significant neurologic disease that is not related to the malignancy
  • No peripheral neuropathy ≥ grade 2
  • No nerve damage from diabetes

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception during and for 4 weeks after completion of study treatment
  • No known allergic reaction to study drugs
  • No active infection
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other pre-existing clinically significant disease that is not related to the malignancy
  • No other serious or significant medical condition that would preclude study participation
  • No other contraindication to study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy for the malignancy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy for the malignancy

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • No concurrent surgery for the malignancy

Other

  • More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing products
  • No other concurrent investigational or commercial agents or therapies for the malignancy

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Central Jersey Oncology Center, PA - East Brunswick

    East Brunswick, New Jersey, 08816

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Mountainside Hospital Cancer Center

    Montclair, New Jersey, 07042

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962-1956

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901-1780

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • UMDNJ University Hospital

    Newark, New Jersey, 07103

  • Overlook Hospital

    Summit, New Jersey, 07902-0220

Other trials in United States

About this study

Official title: A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory 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. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the antitumor activity of trastuzumab (Herceptin^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer.

Secondary

  • Determine the pathological complete response in patients treated with this regimen.
  • Determine the disease-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

  • Course 1 (days 1-28): Patients receive trastuzumab (Herceptin^®) IV over 30-90 minutes on days 1, 8, 15, and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8.
  • Course 2-6: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 during courses 2-5 and on days 1, 8, 15, and 22 during course 6. Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 5 additional courses (6 courses total) in the absence of disease progression or unacceptable toxicity.

Three weeks after completion of course 6, patients undergo restaging. Patients with local operable disease undergo modified radical mastectomy or lumpectomy and axillary node dissection followed by radiotherapy. Patients also receive trastuzumab IV once every 3 weeks for up to 52 weeks of total treatment (including the 6 courses of trastuzumab, docetaxel, and carboplatin) in the absence of disease progression or unacceptable toxicity. Patients who do not have local operable disease continue to receive trastuzumab as above.

PROJECTED ACCRUAL: A total of 13-43 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
herceptin, carboplatin, docetaxel, conventional surgery, radiation therapy
Keywords
inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.

  • herceptinBiological

    Also called trastuzumb

  • carboplatinDrug

  • docetaxelDrug

    Also called Taxotere

  • conventional surgeryProcedure or surgery

    Modified radical mastectomy or lumpectomy and axillary node dissection

  • radiation therapyProcedure or surgery

    Whole breast or chest wall irradiation (as determined by radiologist)

Study groups in NCT00118053
Study groupRoleWhat they receive
Docetaxel, Carboplatin and TrastuzumabExperimentalA total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.
Receives: Biological: herceptin; Drug: carboplatin; Drug: docetaxel; Procedure: conventional surgery; Procedure: radiation therapy

What is being measured

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

  1. Antitumor Activity as Measured by Response Rate

    Measured: 5 years

Secondary outcomes (3)

  1. Pathological Complete Response

    Measured: 5 years

  2. Disease-free Survival

    Measured: 10 years

  3. Pathologic and Molecular Markers for Predicting Efficacy

    Measured: 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 posted11 Jul 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionDec 2008
  4. Study completionDec 2008

Why it stopped: slow accrual

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
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118053
Sponsor's protocol ID
040412;CDR0000433511
Other IDs
P30CA072720, CINJ-040412, 0220045191, CINJ-NJ1104
Status last verified
Sep 2013
First submitted
8 Jul 2005
Last updated
20 Nov 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing herceptin, carboplatin and docetaxel in people with Breast Cancer, run by University of Medicine and Dentistry of New Jersey 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?

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 20 Nov 2013. 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 Nov 2013). 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?

Antitumor Activity as Measured by Response Rate (time frame: 5 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 NCT00118053.

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 20 Nov 2013.

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