Breast CancerPhase 2NCT00003539
Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer
A Phase 2 study testing trastuzumab and paclitaxel in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal 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?
- trastuzumab and paclitaxel
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Feb 2003
- 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 recurrent or metastatic breast cancer Bidimensionally measurable disease No bone scan abnormalities alone Lytic lesions allowed in conjunction with bone scan abnormalities No pure blastic bone metastases No pleural or peritoneal effusions No previously irradiated lesions Resected disease not allowed No brain metastases or leptomeningeal disease Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1500/mm3 Hemoglobin at least 8.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Calcium no greater than 11.0 mg/dL Cardiovascular: No history of arrhythmias No history of other significant cardiac diseases No New York Heart Association class III or IV cardiac function Left ventricular ejection fraction at least 50% Pulmonary: No symptomatic lymphangitic pulmonary metastases Other: Not pregnant Negative pregnancy test No history of other malignancy except: Carcinoma in situ of the cervix Curatively treated nonmelanoma skin cancer No severe infection No severe malnutrition No other serious medical illness No history of grade 3-4 peripheral neuropathy
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No more than 3 prior chemotherapy regimens as adjuvant/neoadjuvant therapy or for disease At least 1 year since prior paclitaxel or docetaxel Prior anthracycline (doxorubicin or epirubicin) or mitoxantrone-based regimen allowed as adjuvant therapy or for advanced disease No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy Radiotherapy: No radiotherapy to greater than 50% of marrow At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherepy to the only measurable lesion Surgery: At least 2-3 weeks since prior surgery and recovered No concurrent surgery to the only measurable lesion Other: No concurrent nonprotocol treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Study of Weekly 1-Hour Paclitaxel (Taxol) Plus Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in the Treatment of Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the therapeutic efficacy of paclitaxel in combination with monoclonal antibody HER2 (Herceptin) in women with recurrent or metastatic breast cancer. II. Evaluate the safety of this combination regimen in these patients.
OUTLINE: Patients are stratified by tumor expression of HER2 (overexpression vs normal). Patients receive a loading dose of monoclonal antibody HER2 (Herceptin) intravenously over 90 minutes on day 0. Paclitaxel is administered intravenously over 1 hour on day 1. Starting on day 7, patients receive paclitaxel by infusion over 1 hour every 7 days. Monoclonal antibody HER2 is administered intravenously over 30 minutes immediately following paclitaxel every 7 days. Treatment continues in the absence of disease progression and unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: This study will accrue 50 patients in approximately 6 months.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, paclitaxel
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2004 (estimated)
- Study startApr 1998
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Andrew D. Seidman, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003539
- Sponsor's protocol ID
- 98-028
- Other IDs
- CDR0000066593, NCI-G98-1473
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jun 2013
- Results posted
- No
Publications
Seidman AD, Fornier MN, Esteva FJ, Tan L, Kaptain S, Bach A, Panageas KS, Arroyo C, Valero V, Currie V, Gilewski T, Theodoulou M, Moynahan ME, Moasser M, Sklarin N, Dickler M, D'Andrea G, Cristofanilli M, Rivera E, Hortobagyi GN, Norton L, Hudis CA. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol. 2001 May 15;19(10):2587-95. doi: 10.1200/JCO.2001.19.10.2587.
PubMed 11352950Seidman AD, Fornier M, Esteva F, et al.: Final report: weekly herceptin and taxol for metastatic breast cancer: analysis of efficacy by HER2 immunophenotype [immunohistochemistry (IHC)] and gene amplification [fluorescent in-situ hybridization (FISH)]. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A319, 2000.
Fornier M, Seidman AD, Esteva FJ, et al.: Weekly herceptin plus one hour taxol: phase II study in HER2 overexpressing (H2+) and non-overexpressing (H2-) metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A482, 1999.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly 1-Hour Paclitaxel (Taxol) Plus Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in the Treatment of Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003539
- Acronym / sponsor ID
- 98-028
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1998
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 4 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer.
Detailed description
OBJECTIVES: I. Determine the therapeutic efficacy of paclitaxel in combination with monoclonal antibody HER2 (Herceptin) in women with recurrent or metastatic breast cancer. II. Evaluate the safety of this combination regimen in these patients.
OUTLINE: Patients are stratified by tumor expression of HER2 (overexpression vs normal). Patients receive a loading dose of monoclonal antibody HER2 (Herceptin) intravenously over 90 minutes on day 0. Paclitaxel is administered intravenously over 1 hour on day 1. Starting on day 7, patients receive paclitaxel by infusion over 1 hour every 7 days. Monoclonal antibody HER2 is administered intravenously over 30 minutes immediately following paclitaxel every 7 days. Treatment continues in the absence of disease progression and unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: This study will accrue 50 patients in approximately 6 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Biological | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Results publication: PubMed 11352950Seidman AD, Fornier MN, Esteva FJ, Tan L, Kaptain S, Bach A, Panageas KS, Arroyo C, Valero V, Currie V, Gilewski T, Theodoulou M, Moynahan ME, Moasser M, Sklarin N, Dickler M, D'Andrea G, Cristofanilli M, Rivera E, Hortobagyi GN, Norton L, Hudis CA. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol. 2001 May 15;19(10):2587-95. doi: 10.1200/JCO.2001.19.10.2587.
- Results publicationSeidman AD, Fornier M, Esteva F, et al.: Final report: weekly herceptin and taxol for metastatic breast cancer: analysis of efficacy by HER2 immunophenotype [immunohistochemistry (IHC)] and gene amplification [fluorescent in-situ hybridization (FISH)]. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A319, 2000.
- Results publicationFornier M, Seidman AD, Esteva FJ, et al.: Weekly herceptin plus one hour taxol: phase II study in HER2 overexpressing (H2+) and non-overexpressing (H2-) metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A482, 1999.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D. Seidman, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab and paclitaxel in people with Breast Cancer, run by Memorial Sloan Kettering Cancer 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 24 Jun 2013. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003539, which also lists 3 linked publications.
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 24 Jun 2013.