AzTrials
AzTrials

Breast CancerPhase 2NCT00182793

Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

A Phase 2 study testing trastuzumab, carboplatin and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical Center 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
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages Up to 65 years
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab, carboplatin and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Jul 2005to Oct 2014
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 Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
  • Stage IIIB or IIIC disease, meeting both of the following criteria:
  • Must have received prior neoadjuvant or adjuvant therapy
  • Must have undergone lumpectomy or mastectomy
  • Stage IV disease, meeting all of the following criteria:
  • Only 1-3 organ sites with disease involvement after induction chemotherapy
  • Achieved at least a partial response after induction chemotherapy
  • No more than 3 lesions in the organ sites combined
  • Inflammatory breast cancer allowed
  • Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • 65 and under

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • SGOT or SGPT ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine ≤ 1.2 mg/dL
  • Creatinine clearance ≥ 70 mL/min

Cardiovascular

  • LVEF ≥ 55% by MUGA or echocardiogram

Pulmonary

  • FEV_1 ≥ 60% of predicted
  • DLCO ≥ 60% of the lower limit of predicted value
  • Oxygen saturation > 92% on room air

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No autoimmune disorders
  • No immunosuppressive condition
  • No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy except trastuzumab (Herceptin®)

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to adjacent or involved sites of disease that would preclude study radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other concurrent anticancer therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

Other trials in United States

About this study

Official title: Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB, IIIC, or IV breast cancer.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients undergo stem cell collection.

  • Course 1: Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2.
  • Course 2: Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation.

After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Conditions
Breast Cancer
Keywords
stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, inflammatory breast cancer, male breast cancer, recurrent breast cancer, invasive ductal breast carcinoma with predominant intraductal component, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, Paget disease of the breast with invasive ductal carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, comedo ductal breast carcinoma
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms, Breast Neoplasms, Male, Carcinoma, Ductal, Breast, Carcinoma, Lobular

What participants receive

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

  • trastuzumabBiological

    Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion

  • carboplatinDrug

    Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

  • cyclophosphamideDrug

    Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

  • melphalanDrug

    Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion

  • thiotepaDrug

    Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

  • adjuvant therapyProcedure or surgery

    Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy.

  • autologous-autologous tandem hematopoietic stem cell transplantationProcedure or surgery

    Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation.

  • bone marrow ablation with stem cell supportProcedure or surgery

    Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation

  • radiation therapyRadiation

    After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy.

    Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy.

Study groups in NCT00182793
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
Receives: Biological: trastuzumab; Drug: melphalan; Procedure: adjuvant therapy; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Procedure: bone marrow ablation with stem cell support; Radiation: radiation therapy
Arm IIExperimentalPatients undergo stem cell collection. Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
Receives: Drug: carboplatin; Drug: cyclophosphamide; Drug: thiotepa; Procedure: adjuvant therapy; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Procedure: bone marrow ablation with stem cell support; Radiation: radiation therapy

What is being measured

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

  1. 5-Year Relapse-free Survival Rate

    Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.

    Measured: From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment

  2. 5-Year Overall Survival Rate

    Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up

    Measured: From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00182793
Sponsor's protocol ID
05042
Other IDs
P30CA033572, CDR0000442105
Status last verified
Jan 2017
First submitted
15 Sep 2005
Last updated
23 Feb 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab, carboplatin and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical Center 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 23 Feb 2017. 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?

Yes. Results are posted in the registry (first posted 23 Feb 2017). 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?

5-Year Relapse-free Survival Rate (time frame: From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment). 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 NCT00182793.

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 23 Feb 2017.

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