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Aggressive chemo combo with stem cell rescue tested for rare breast cancer

NCT ID NCT00003042

Disease control Sponsor: City of Hope Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tested a very strong chemotherapy regimen followed by a stem cell transplant in 41 people with stage IIIB inflammatory breast cancer. The goal was to see if this intense approach could help keep the cancer from coming back and improve survival. Participants received several chemotherapy drugs, then had their own stem cells returned to help the body recover.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (cisplatin, cyclophosphamide, doxorubicin, melphalan, paclitaxel, tamoxifen) plus stem cell transplant
What this could lead to
If successful, this approach could offer a more aggressive treatment option for inflammatory breast cancer, potentially improving relapse-free and overall survival.
What could go wrong
This is a small, completed phase II trial with only 41 participants, so results may not apply broadly. High-dose chemotherapy carries serious risks like infection, organ damage, and treatment-related death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

May 1997

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm inflammatory breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.