Breast CancerPhase 1/2NCT00028977
Herbal Therapy in Treating Women With Metastatic Breast Cancer
A Phase 1/2 study testing herba scutellaria barbata and herba scutellaria Barbatae (HSB) in people with Breast Cancer, run by University of California, San Francisco at 2 sites in United States.
Trial summary
RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth of cancer cells and may be an effective treatment for metastatic breast cancer. PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer. 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?
- herba scutellaria barbata and herba scutellaria Barbatae (HSB)
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2001to Apr 2006
- Phase
- Phase 1/2
- 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 breast cancer (may include original primary cancer diagnosis)
- Measurable disease
- Metastatic involvement with minimal or no symptoms
- Solitary metastases require histological confirmation
- No extensive liver involvement (more than 50% of liver parenchyma)
- No lymphangitic pulmonary involvement
- CNS involvement or spinal cord compression allowed if stabilized by therapy for more than 3 months
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- More than 6 months
Hematopoietic:
- WBC at least 2,500/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- See Disease Characteristics
- Bilirubin no greater than 1.7 mg/dL
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of multiple or severe food or medicine allergies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior biologic therapy
- No concurrent anticancer biologic therapy
Chemotherapy:
- At least 1 week since prior chemotherapy
- No concurrent anticancer chemotherapy
Endocrine therapy:
- At least 1 week since prior hormonal therapy
- No concurrent anticancer hormonal therapy
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Recovered from prior anticancer therapy
- At least 1 week since prior investigational agents
- At least 1 week since prior herbal medications
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- Concurrent pamidronate allowed
- Concurrent acupuncture or other nonherbal therapy allowed
- Concurrent nutritional vitamin supplementation (up to 5 times recommended daily allowance) allowed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer Research Network, Incorporated
Plantation, Florida, 33324
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth of cancer cells and may be an effective treatment for metastatic breast cancer.
PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of Scutellaria barbata (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
- Determine the safety and toxicity of this therapy in these patients.
- Determine the feasibility of this therapy in these patients.
- Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
- Determine the quality of life of patients treated with this therapy.
- Determine the bioavailability and pharmacokinetics of this therapy in these patients.
OUTLINE: Patients receive oral Scutellaria barbata (Chinese herbal extract) twice daily for 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- herba scutellaria barbata, herba scutellaria Barbatae (HSB)
- 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.
herba scutellaria barbataDrug
herba scutellaria Barbatae (HSB)Other
Also called Traditional Chinese Medicine
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 startAug 2001
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hope S. Rugo, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028977
- Sponsor's protocol ID
- CDR0000069155
- Other IDs
- UCSF-CRO-00758, UCSF-IND-59521, NCI-G01-2043
- Status last verified
- Sep 2012
- First submitted
- 4 Jan 2002
- Last updated
- 17 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00028977
- Acronym / sponsor ID
- CDR0000069155
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2001
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 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.
RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth of cancer cells and may be an effective treatment for metastatic breast cancer.
PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of Scutellaria barbata (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
- Determine the safety and toxicity of this therapy in these patients.
- Determine the feasibility of this therapy in these patients.
- Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
- Determine the quality of life of patients treated with this therapy.
- Determine the bioavailability and pharmacokinetics of this therapy in these patients.
OUTLINE: Patients receive oral Scutellaria barbata (Chinese herbal extract) twice daily for 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| herba scutellaria barbata | Drug | – |
| herba scutellaria Barbatae (HSB)Also: Traditional Chinese Medicine | Other | – |
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 17 Sep 2012.
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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.
Hope S. Rugo, MD study chair
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing herba scutellaria barbata and herba scutellaria Barbatae (HSB) in people with Breast Cancer, run by University of California, San Francisco at 2 sites 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 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 17 Sep 2012.