Breast CancerPhase 3NCT00002544
Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
A Phase 3 study testing docetaxel and mitoxantrone hydrochloride in people with Breast Cancer, run by Arbeitsgemeinschaft fur Internistische Onkologie at 1 site in Germany.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if mitoxantrone is more effective with or without docetaxel. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel and mitoxantrone hydrochloride
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- May 1993to Nov 2002
- Phase
- Phase 3
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven metastatic breast cancer of poor prognosis, defined by any of the following characteristics:
- Patient aged 35 or under
- Liver metastases
- Lung metastases combined with other disease manifestations
- Lung metastases without other disease manifestations but with a disease free interval of no more than 18 months
- Indication for chemotherapy documented by either:
- Hormone receptor negativity OR
- Hormone resistant disease
- Measurable metastatic disease required
- Nonmeasurable disease includes:
- Metastases verified only histologically
- Tumor parameters not precisely measurable (e.g., bone marrow involvement, lymphangitic disease)
- No CNS metastasis or bone marrow carcinomatosis
- Hormone receptor status:
- Receptor status known
PATIENT CHARACTERISTICS:
Age:
- 80 and under
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC greater than 4,000/mm^3
- Absolute granulocyte count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 6 times ULN
- SGOT and/or SGPT no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.15 times ULN
Cardiovascular:
- No uncontrolled hypertension
- No congestive heart failure within the past 6 months
- No myocardial infarction within the past 6 months
Other:
- Fertile patients must use effective contraception
- No acute or chronic infection
- No second primary tumor
- No other serious illness
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy for metastatic disease
- Greater than 1 year since prior adjuvant chemotherapy
- No prior anthracycline or anthraquinone
Endocrine therapy:
- Hormone resistant disease required of receptor positive patients
- No concurrent endocrine therapy
Radiotherapy:
- No prior mediastinal irradiation
- Adjuvant irradiation of parasternal nodes eligible
- No prior irradiation to more than 25% of bone marrow
- No concurrent irradiation of sole measurable lesion
Surgery:
- Not specified
Other:
- No concurrent anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if mitoxantrone is more effective with or without docetaxel.
PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
Read the detailed description
OBJECTIVES:
- Compare the survival and quality of life scores (composed of time to progression, WHO performance status, subjective patient evaluation, and subjective adverse event profile) among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease.
- Compare the remission rate, time to remission, remission duration, time to best response, objective adverse events, and patient acceptance of treatment on these 2 regimens.
- Investigate which prognostic subgroups of women benefit from treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, treatment center, disease free interval (no more than 18 months vs more than 18 months), hormone receptor status (positive or unknown vs negative), prior adjuvant therapy with anthracyclines (yes vs no), presence of liver metastases (liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement), and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive mitoxantrone IV on day 1. Treatment repeats every 3 weeks until disease progression, unacceptable toxicity, or maximum cumulative dose. Patients who achieve complete response receive 2 additional courses.
- Arm II: Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
At relapse, reinduction with the original regimen is attempted. Following a second complete response, 2 additional courses of consolidative treatment are given, and patients are then followed off treatment.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, mitoxantrone hydrochloride
- 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.
docetaxelDrug
mitoxantrone hydrochlorideDrug
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 startMay 1993
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft fur Internistische Onkologie
- Sponsor type
- University, hospital or other
- Investigators
- Else G. Heidemann, MD, Study chair, Diakonie-Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002544
- Sponsor's protocol ID
- GER-AIO-01/92
- Other IDs
- CDR0000063279, EU-93011
- Status last verified
- Apr 2001
- First submitted
- 1 Nov 1999
- Last updated
- 2 Aug 2013
- Results posted
- No
Publications
Heidemann E, Souchon R, Stoger H, et al.: First-line monochemotherapy with mitoxantrone versus combination with fluorouracil, epirubicin and cyclophosphamide in high-risk metastatic breast cancer: a prospective randomized multicenter clinical trial. Onkologie 23(1): 54-59, 2000.
Heidemann E, Stoeger H, Souchon R, et al.: Balance of time to progression, quality of life, and overall survival: more gain from treatment in single agent treatment with mitoxantrone (N) than with the combination of fluorouracil, epirubicin, cyclophosphamide (FEC). Results of a multicenter randomized trial in high risk metastatic breast cancer (MBC). [Abstract] Proceedings of the American Society of Clinical Oncology A-284, 74a, 2000.
Loibl S, von Minckwitz G, Souchon R, et al.: Phase I/II study with mitoxantrone (N) vs. NDOC in patients with high risk locally advanced or metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A512, 1999.
Heidemann E, Stoeger H, Souchon R, Hirschmann WD, Bodenstein H, Oberhoff C, Fischer JT, Schulze M, Clemens M, Andreesen R, Mahlke M, Konig M, Scharl A, Fehnle K, Kaufmann M. Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial. Ann Oncol. 2002 Nov;13(11):1717-29. doi: 10.1093/annonc/mdf306.
PubMed 12419743
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS
- ClinicalTrials.gov ID
- NCT00002544
- Acronym / sponsor ID
- GER-AIO-01/92
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Arbeitsgemeinschaft fur Internistische OnkologieUniversity, hospital or other
- Study start
- May 1993
- Study completion
- Nov 2002 (actual)
- First posted
- 27 Jan 2003 (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. It is not yet known if mitoxantrone is more effective with or without docetaxel.
PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
Detailed description
OBJECTIVES:
- Compare the survival and quality of life scores (composed of time to progression, WHO performance status, subjective patient evaluation, and subjective adverse event profile) among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease.
- Compare the remission rate, time to remission, remission duration, time to best response, objective adverse events, and patient acceptance of treatment on these 2 regimens.
- Investigate which prognostic subgroups of women benefit from treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, treatment center, disease free interval (no more than 18 months vs more than 18 months), hormone receptor status (positive or unknown vs negative), prior adjuvant therapy with anthracyclines (yes vs no), presence of liver metastases (liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement), and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive mitoxantrone IV on day 1. Treatment repeats every 3 weeks until disease progression, unacceptable toxicity, or maximum cumulative dose. Patients who achieve complete response receive 2 additional courses.
- Arm II: Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
At relapse, reinduction with the original regimen is attempted. Following a second complete response, 2 additional courses of consolidative treatment are given, and patients are then followed off treatment.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| docetaxel | Drug | – |
| mitoxantrone hydrochloride | 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 2 Aug 2013.
- BackgroundHeidemann E, Souchon R, Stoger H, et al.: First-line monochemotherapy with mitoxantrone versus combination with fluorouracil, epirubicin and cyclophosphamide in high-risk metastatic breast cancer: a prospective randomized multicenter clinical trial. Onkologie 23(1): 54-59, 2000.
- BackgroundHeidemann E, Stoeger H, Souchon R, et al.: Balance of time to progression, quality of life, and overall survival: more gain from treatment in single agent treatment with mitoxantrone (N) than with the combination of fluorouracil, epirubicin, cyclophosphamide (FEC). Results of a multicenter randomized trial in high risk metastatic breast cancer (MBC). [Abstract] Proceedings of the American Society of Clinical Oncology A-284, 74a, 2000.
- BackgroundLoibl S, von Minckwitz G, Souchon R, et al.: Phase I/II study with mitoxantrone (N) vs. NDOC in patients with high risk locally advanced or metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A512, 1999.
- Results publication: PubMed 12419743Heidemann E, Stoeger H, Souchon R, Hirschmann WD, Bodenstein H, Oberhoff C, Fischer JT, Schulze M, Clemens M, Andreesen R, Mahlke M, Konig M, Scharl A, Fehnle K, Kaufmann M. Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial. Ann Oncol. 2002 Nov;13(11):1717-29. doi: 10.1093/annonc/mdf306.
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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.
Else G. Heidemann, MD study chair
Diakonie-Klinikum Stuttgart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel and mitoxantrone hydrochloride in people with Breast Cancer, run by Arbeitsgemeinschaft fur Internistische Onkologie at 1 site in Germany.
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 2 Aug 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00002544, which also lists 4 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 2 Aug 2013.