BRCA1 MutationPhase 2CisplatinNCT01611727
Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients
A Phase 2 study testing Cisplatin in people with BRCA1 Mutation and Metastatic Breast Cancer, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA1 Mutation, Metastatic Breast Cancer
- What is being tested?
- Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2007to Apr 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years, with measurable (defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14)) metastatic (stage IV) breast cancer, and who are known to carry a BRCA1 mutation, are eligible.
- In addition, the following are required:
- adequate hematologic
- renal, and hepatic function
- adequate recovery from recent surgery and/or radiation therapy
- recovery from all prior treatment-related toxicities (to grade < 2 according to National Cancer Institute Common Toxicity Criteria, Version3.0, except alopecia)
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- life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. -
- Patients could have received up to four prior chemotherapies for metastatic disease.
Who cannot join
- Patients with known brain metastases are not eligible.
- Patients previously treated with a platinum-based chemotherapy are not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer
Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage.
It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.
- Conditions
- BRCA1 Mutation, Metastatic Breast Cancer
- Being tested
- Cisplatin
- Keywords
- BRCA1, survival, metastatic disease, cisplatin
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin chemotherapy will be administered as a 75 mg/m2 intravenous (IV) infusion every 3 weeks, for six cycles. Dexamethasone (8mg) will be administered once daily for three days after chemotherapy. Ondansetron (Zofran™) will be used for anti-nausea prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | Not described Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate
This is defined as the percentage of patients who achieved a complete response or partial response by RECIST criteria within the first six months.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BRCA1 MutationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology
- Responsible party
- Principal investigator, Tomasz Byrski, MD, PhD, Pomeranian Medical University Szczecin
- Investigators
- Tomasz Byrski, MD, PhD, Principal investigator, Pomenarian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611727
- Sponsor's protocol ID
- BN-001/83/07
- Acronym
- Cisplatin
- Status last verified
- Jul 2012
- First submitted
- 31 May 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Byrski T, Dent R, Blecharz P, Foszczynska-Kloda M, Gronwald J, Huzarski T, Cybulski C, Marczyk E, Chrzan R, Eisen A, Lubinski J, Narod SA. Results of a phase II open-label, non-randomized trial of cisplatin chemotherapy in patients with BRCA1-positive metastatic breast cancer. Breast Cancer Res. 2012 Jul 20;14(4):R110. doi: 10.1186/bcr3231.
PubMed 22817698
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-Label, Non-Randomized Trial of Cisplatin Chemotherapy in Patients With BRCA1-Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01611727
- Acronym / sponsor ID
- Cisplatin / BN-001/83/07
- Conditions
- BRCA1 Mutation, Metastatic Breast Cancer
- Keywords
- BRCA1, survival, metastatic disease, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Jun 2012 (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.
Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage.
It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients aged ≥ 18 years, with measurable (defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14)) metastatic (stage IV) breast cancer, and who are known to carry a BRCA1 mutation, are eligible.
- In addition, the following are required:
- Patients could have received up to four prior chemotherapies for metastatic disease.
Key exclusion criteria (2 listed)
- Patients with known brain metastases are not eligible.
- Patients previously treated with a platinum-based chemotherapy are not eligible.
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 |
|---|---|---|
| CisplatinCisplatin chemotherapy will be administered as a 75 mg/m2 intravenous (IV) infusion every 3 weeks, for six cycles. Dexamethasone (8mg) will be administered once daily for three days after chemotherapy. Ondansetron (Zofran™) will be used for anti-nausea prophylaxis. | Drug | Cisplatin |
Primary outcome
Tumor Response Rate
Time frame: Six Months
This is defined as the percentage of patients who achieved a complete response or partial response by RECIST criteria within the first six months.
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 12 Jul 2012.
- Derived from this study: PubMed 22817698Byrski T, Dent R, Blecharz P, Foszczynska-Kloda M, Gronwald J, Huzarski T, Cybulski C, Marczyk E, Chrzan R, Eisen A, Lubinski J, Narod SA. Results of a phase II open-label, non-randomized trial of cisplatin chemotherapy in patients with BRCA1-positive metastatic breast cancer. Breast Cancer Res. 2012 Jul 20;14(4):R110. doi: 10.1186/bcr3231.
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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.
Tomasz Byrski, MD, PhD principal investigator
Pomenarian Medical University
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 Cisplatin in people with BRCA1 Mutation and Metastatic Breast Cancer, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 9 inclusion and 2 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 12 Jul 2012. 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 Poland. 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?
Tumor Response Rate (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611727, which also lists 1 linked publication.
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 12 Jul 2012.