Male Breast CancerPhase 2NCT00005817
Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
A Phase 2 study testing becatecarin and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer
- What is being tested?
- becatecarin and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to May 2006
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed invasive breast cancer; patients without pathologic or cytologic evidence of metastatic disease should have unequivocal evidence of metastasis on radiographic study or physical exam; patients must have metastatic (stage IV) breast cancer, or locally advanced (stage IIIB) breast cancer that cannot be treated with curative intent
- Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with conventional techniques; lytic bone lesions meeting these criteria will be considered measurable disease
- Patients are required to have had at least one prior chemotherapy regimen for advanced breast cancer unless they have progressed within 12 months of concluding adjuvant chemotherapy; patients may not have had more than 2 prior chemotherapy regimens for advanced breast cancer; treatment with high-dose chemotherapy and stem cell support in the metastatic setting, including induction chemotherapy, will be considered 2 treatment regimens; patients may have received adjuvant chemotherapy; patients who have metastatic breast cancer diagnosed within 12 months of concluding adjuvant chemotherapy will be eligible after 0 or 1 regimens in the metastatic setting; patients may have received prior hormonal therapy of any type; patients may have been previously treated with investigational agents or biological agents (e.g. Herceptin)
- Patients must have concluded prior therapy no less than the duration of one cycle of treatment prior to beginning treatment with rebeccamycin analog, but in all cases there must be at least a 2 week interval since last treatment; thus, if a patient is receiving therapy every three weeks, the patient must be at least three weeks from the last treatment before beginning protocol-based therapy; patients must have recovered from the toxicities of prior therapy, and meet the performance status and laboratory criteria for eligibility before beginning treatment
- Patients may not receive concurrent anti-neoplastic therapy; all other radiation therapy, hormonal therapy, or treatment with trastuzumab (Herceptin) must be stopped prior to treatment on protocol; patients receiving bisphosphonate therapy may continue to receive these treatments while on protocol
- Life expectancy of greater than 3 months
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- ECOG performance status =< 1 (Karnofsky >= 70%)
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal
- Creatinine =< 2 mg/dl
- Sodium (Na) within normal institutional limits
- Serum lipase within normal institutional limits
- Serum amylase within normal institutional limits
- Because rebeccamycin analog has been associated with phlebitis, all therapy on protocol will be given through a central venous line; patients not willing to have a central line, or those in whom central venous access could not be established, will not be eligible
- The effects of rebeccamycin analog on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation; women should not become pregnant or nurse, nor expect to become pregnant or nurse, during the study; women in whom there is a suspicion of possible pregnancy must have a documented negative serum pregnancy test prior to beginning therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 10 mm with conventional techniques) and truly non-measurable lesions, which include the following:
- Bone lesions, except pure lytic lesions
- Leptomeningeal disease
- Tumor markers
- Ascites
- Pleural/pericardial effusions
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- Patients who have had radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to prior chemotherapy administered previously
- Patients may not be receiving any other investigational anti-neoplastic agents, with the following exceptions: patients may participate in concurrent studies of supportive therapies, including anti-nausea or bisphosphonate-based treatments
- Patients with known brain metastases may be included if they meet the following 2 criteria:
- Completed whole brain irradiation at least two months prior to study entry
- Have no symptoms from brain metastases
- Lack of central venous access
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on study
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Phase 2 Study of Rebeccamycin Analog in Advanced Breast Cancer
Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. The best way to give rebeccamycin analog in breast cancer patients is not yet known
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the activity of rebeccamycin analog as therapy for advanced breast cancer when administered in two different treatment schedules.
SECONDARY OBJECTIVES:
- To assess the toxicity associated with administration of rebeccamycin analog therapy in women with advanced breast cancer.
II. To evaluate topoisomerase I and II levels in human lymphocytes following treatment with rebeccamycin analog.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive rebeccamycin analogue IV over 60 minutes on day 1.
Arm II: Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5.
In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Conditions
- Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer
- Being tested
- becatecarin, laboratory biomarker analysis
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
becatecarinDrug
Also called BMS-181176, rebeccamycin analogue, rebeccamycin analogue, tartrate salt, XL119
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (becatecarin) | Experimental | Patients receive rebeccamycin analogue IV over 60 minutes on day 1. Receives: Drug: becatecarin; Other: laboratory biomarker analysis |
| Arm II (becatecarin) | Experimental | Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5. Receives: Drug: becatecarin; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates (complete or partial response) of 2 different schedules of rebeccamycin analog
Measured: Up to 6 years
Toxicity rates of rebeccamycin analog as assessed by the NCI CTC version 2.0
Measured: Up to 6 years
Secondary outcomes (1)
Change in topoisomerase (TOPO I and II) levels in circulating lymphocytes
Changes in TOPO levels will be described as a function of treatment and time since exposure in order to establish whether rebeccamycin acts as an inhibitor of these enzymes.
Measured: From baseline to up to 6 years
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 startMar 2000
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Harold Burstein, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005817
- Sponsor's protocol ID
- NCI-2013-00031
- Other IDs
- 99-283, U01CA062502, CDR0000067821
- Status last verified
- Jan 2013
- First submitted
- 2 Jun 2000
- Last updated
- 1 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Rebeccamycin Analog in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00005817
- Acronym / sponsor ID
- NCI-2013-00031
- Conditions
- Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2000
- Primary completion
- May 2006 (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.
Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. The best way to give rebeccamycin analog in breast cancer patients is not yet known
Detailed description
PRIMARY OBJECTIVES:
- To assess the activity of rebeccamycin analog as therapy for advanced breast cancer when administered in two different treatment schedules.
SECONDARY OBJECTIVES:
- To assess the toxicity associated with administration of rebeccamycin analog therapy in women with advanced breast cancer.
II. To evaluate topoisomerase I and II levels in human lymphocytes following treatment with rebeccamycin analog.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive rebeccamycin analogue IV over 60 minutes on day 1.
Arm II: Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5.
In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (becatecarin) | Experimental | Drug: becatecarin, Other: laboratory biomarker analysisPatients receive rebeccamycin analogue IV over 60 minutes on day 1. |
| Arm II (becatecarin) | Experimental | Drug: becatecarin, Other: laboratory biomarker analysisPatients receive rebeccamycin analogue IV over 60 minutes on days 1-5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have histologically or cytologically confirmed invasive breast cancer; patients without pathologic or cytologic evidence of metastatic disease should have unequivocal evidence of metastasis on radiographic study or physical exam; patients must have metastatic (stage IV) breast cancer, or locally advanced (stage IIIB) breast cancer that cannot be treated with curative intent
- Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with conventional techniques; lytic bone lesions meeting these criteria will be considered measurable disease
- Patients are required to have had at least one prior chemotherapy regimen for advanced breast cancer unless they have progressed within 12 months of concluding adjuvant chemotherapy; patients may not have had more than 2 prior chemotherapy regimens for advanced breast cancer; treatment with high-dose chemotherapy and stem cell support in the metastatic setting, including induction chemotherapy, will be considered 2 treatment regimens; patients may have received adjuvant chemotherapy; patients who have metastatic breast cancer diagnosed within 12 months of concluding adjuvant chemotherapy will be eligible after 0 or 1 regimens in the metastatic setting; patients may have received prior hormonal therapy of any type; patients may have been previously treated with investigational agents or biological agents (e.g. Herceptin)
- Patients must have concluded prior therapy no less than the duration of one cycle of treatment prior to beginning treatment with rebeccamycin analog, but in all cases there must be at least a 2 week interval since last treatment; thus, if a patient is receiving therapy every three weeks, the patient must be at least three weeks from the last treatment before beginning protocol-based therapy; patients must have recovered from the toxicities of prior therapy, and meet the performance status and laboratory criteria for eligibility before beginning treatment
- Patients may not receive concurrent anti-neoplastic therapy; all other radiation therapy, hormonal therapy, or treatment with trastuzumab (Herceptin) must be stopped prior to treatment on protocol; patients receiving bisphosphonate therapy may continue to receive these treatments while on protocol
Key exclusion criteria (15 listed)
- Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 10 mm with conventional techniques) and truly non-measurable lesions, which include the following:
- Patients who have had radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to prior chemotherapy administered previously
- Patients may not be receiving any other investigational anti-neoplastic agents, with the following exceptions: patients may participate in concurrent studies of supportive therapies, including anti-nausea or bisphosphonate-based treatments
- Patients with known brain metastases may be included if they meet the following 2 criteria:
- Lack of central venous access
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 |
|---|---|---|
| becatecarinAlso: BMS-181176, rebeccamycin analogue, rebeccamycin analogue, tartrate salt, XL119Given IV | Drug | Arm I (becatecarin), Arm II (becatecarin) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (becatecarin), Arm II (becatecarin) |
Primary outcome
Response rates (complete or partial response) of 2 different schedules of rebeccamycin analog
Time frame: Up to 6 years
Toxicity rates of rebeccamycin analog as assessed by the NCI CTC version 2.0
Time frame: Up to 6 years
1 secondary outcome
Change in topoisomerase (TOPO I and II) levels in circulating lymphocytes
Time frame: From baseline to up to 6 years
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 1 Feb 2013.
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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.
Harold Burstein principal investigator
Dana-Farber Cancer Institute
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 becatecarin and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) 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?
The sponsor lists 18 inclusion and 15 exclusion criteria. 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 1 Feb 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.
What does the primary outcome measure?
Response rates (complete or partial response) of 2 different schedules of rebeccamycin analog (time frame: Up to 6 years). 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 1 Feb 2013.