Breast CancerPhase 2NCT00003042
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
A Phase 2 study testing filgrastim, cisplatin and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, cisplatin and cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 1997to 6 Nov 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin
- Diagnosis within the past 6 months
PATIENT CHARACTERISTICS:
Age:
- 60 and under
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGOT or SGPT no greater than 1.5 times the upper limit of normal
Renal:
- Creatinine less than 1.2 mg/dL
- Creatinine clearance at least 80 mL/min
- No history of hemorrhagic cystitis
Cardiovascular:
- Left ventricular fraction at least 55% on MUGA scan
- No previous valvular heart disease or arrhythmia
Pulmonary:
- FEV_1 at least 60% predicted
- Room air pO_2 greater than 85 mmHg
- Room air pCO_2 no greater than 43 mmHg
- DLCO at least 60% of the lower limit of predicted value
Other:
- No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer
- No organic CNS dysfunction
- Not pregnant
- No known and potentially disabling psychosocial history
- Not positive for hepatitis B or HIV
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Stratum 1:
- No more than one cycle of chemotherapy
- Stratum 2:
- No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel during previous chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiation to the left chest wall
Surgery:
- Modified radical mastectomy allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the effectiveness of neoadjuvant dose intensive sequential chemotherapy, followed by surgical resection, adjuvant therapy, and tandem high dose chemotherapy and stem cell rescue in patients with inflammatory stage IIIB breast cancer.
- Determine the clinical and pathological remission rate (complete, partial, and overall) following neoadjuvant dose dependent sequential chemotherapy in patients with inflammatory stage IIIB breast cancer.
- Determine the relapse and survival rate of these patients with the above therapy.
- Determine the potential correlations between inflammatory features and hereditary background.
OUTLINE: Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy (stratum 1) and those who have had more than 1 cycle of neoadjuvant chemotherapy and/or modified radical mastectomy (stratum 2).
Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4, 15-19, and 29-32. Paclitaxel is infused over 96 hours on days 43-47 and 57-60. Filgrastim (G-CSF) is administered on days 5-10, 20-25, 33-38, 48-55, and 61-68, and beyond if the granulocyte count is less than 1000/mm^3. A modified radical mastectomy is performed between days 70 and 80. All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104, and cyclophosphamide IV on day 121. Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135. Stem cells are harvested from the patient on days 113-116 and days 132-135.
High-dose chemotherapy is then administered to all patients in the study. Course 1 starts with doxorubicin IV on days -7 to -3. Paclitaxel IV is administered for 24 hours on day -2. Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000/mm^3 for 3 days. Peripheral stem cells are reinfused on day 0. Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11. Filgrastim is administered IV on days -10 to -6. Melphalan and cisplatin are administered again on day -4. Stem cells are infused on day -3 and on day 0. Filgrastim is then administered until the granulocyte count is at least 1000/mm^3 for 3 days.
Radiation therapy is started 4-7 weeks after the beginning of course 2. Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors.
Patients are followed every 3 months for two years and then annually for the next three years.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued, at a rate of about 15 per year.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, cisplatin, cyclophosphamide, doxorubicin hydrochloride, melphalan
- Keywords
- stage IIIB breast cancer, inflammatory 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.
filgrastimBiological
cisplatinDrug
cyclophosphamideDrug
melphalanDrug
mesnaDrug
paclitaxelDrug
tamoxifen citrateDrug
bone marrow ablation with stem cell supportProcedure or surgery
conventional surgeryProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 cycle of neoadjuvant chemotherapy | Experimental | Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. Receives: Biological: filgrastim; Drug: cisplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: melphalan; Drug: mesna; Drug: paclitaxel; Drug: tamoxifen citrate; Procedure: bone marrow ablation with stem cell support; Procedure: conventional surgery; Procedure: peripheral blood stem cell transplantation |
| More than 1 cycle of neoadjuvant chemotherapy | Experimental | Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. Receives: Biological: filgrastim; Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: melphalan; Drug: mesna; Drug: paclitaxel; Drug: tamoxifen citrate; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year Relapse-free Survival
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment.
Measured: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.
Five-year Overall Survival
Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause.
Measured: From date of mastectomy until date of death, 5 years post mastectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start30 May 1997
- Primary completion9 Feb 2010
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George Somlo, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003042
- Sponsor's protocol ID
- 96139
- Other IDs
- P30CA033572, CHNMC-96139, NCI-G97-1288, CDR0000065672
- Status last verified
- Feb 2026
- First submitted
- 1 Nov 1999
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
- ClinicalTrials.gov ID
- NCT00003042
- Acronym / sponsor ID
- 96139
- Conditions
- Breast Cancer
- Keywords
- stage IIIB breast cancer, inflammatory breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 May 1997 (actual)
- Primary completion
- 9 Feb 2010 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 8 Apr 2021
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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
Detailed description
OBJECTIVES:
- Determine the effectiveness of neoadjuvant dose intensive sequential chemotherapy, followed by surgical resection, adjuvant therapy, and tandem high dose chemotherapy and stem cell rescue in patients with inflammatory stage IIIB breast cancer.
- Determine the clinical and pathological remission rate (complete, partial, and overall) following neoadjuvant dose dependent sequential chemotherapy in patients with inflammatory stage IIIB breast cancer.
- Determine the relapse and survival rate of these patients with the above therapy.
- Determine the potential correlations between inflammatory features and hereditary background.
OUTLINE: Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy (stratum 1) and those who have had more than 1 cycle of neoadjuvant chemotherapy and/or modified radical mastectomy (stratum 2).
Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4, 15-19, and 29-32. Paclitaxel is infused over 96 hours on days 43-47 and 57-60. Filgrastim (G-CSF) is administered on days 5-10, 20-25, 33-38, 48-55, and 61-68, and beyond if the granulocyte count is less than 1000/mm^3. A modified radical mastectomy is performed between days 70 and 80. All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104, and cyclophosphamide IV on day 121. Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135. Stem cells are harvested from the patient on days 113-116 and days 132-135.
High-dose chemotherapy is then administered to all patients in the study. Course 1 starts with doxorubicin IV on days -7 to -3. Paclitaxel IV is administered for 24 hours on day -2. Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000/mm^3 for 3 days. Peripheral stem cells are reinfused on day 0. Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11. Filgrastim is administered IV on days -10 to -6. Melphalan and cisplatin are administered again on day -4. Stem cells are infused on day -3 and on day 0. Filgrastim is then administered until the granulocyte count is at least 1000/mm^3 for 3 days.
Radiation therapy is started 4-7 weeks after the beginning of course 2. Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors.
Patients are followed every 3 months for two years and then annually for the next three years.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued, at a rate of about 15 per year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 cycle of neoadjuvant chemotherapy | Experimental | Biological: filgrastim, Drug: cisplatin, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: melphalan, Drug: mesna, Drug: paclitaxel, Drug: tamoxifen citrate, Procedure: bone marrow ablation with stem cell support, Procedure: conventional surgery, Procedure: peripheral blood stem cell transplantationPatients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. |
| More than 1 cycle of neoadjuvant chemotherapy | Experimental | Biological: filgrastim, Drug: cisplatin, Drug: doxorubicin hydrochloride, Drug: melphalan, Drug: mesna, Drug: paclitaxel, Drug: tamoxifen citrate, Procedure: bone marrow ablation with stem cell support, Procedure: peripheral blood stem cell transplantationPatients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| filgrastim | Biological | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| cisplatin | Drug | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| cyclophosphamide | Drug | 1 cycle of neoadjuvant chemotherapy |
| doxorubicin hydrochloride | Drug | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| melphalan | Drug | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| mesna | Drug | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| paclitaxel | Drug | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| tamoxifen citrate | Drug | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| bone marrow ablation with stem cell support | Procedure or surgery | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
| conventional surgery | Procedure or surgery | 1 cycle of neoadjuvant chemotherapy |
| peripheral blood stem cell transplantation | Procedure or surgery | 1 cycle of neoadjuvant chemotherapy, More than 1 cycle of neoadjuvant chemotherapy |
Primary outcome
Three-year Relapse-free Survival
Time frame: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment.
Five-year Overall Survival
Time frame: From date of mastectomy until date of death, 5 years post mastectomy.
Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Somlo, MD principal investigator
City of Hope Medical 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 filgrastim, cisplatin 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 20 Feb 2026. 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 8 Apr 2021). 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?
Three-year Relapse-free Survival (time frame: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.). 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?
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 Feb 2026.