Breast CancerPhase 1NCT01674842
Cisplatin + RT for Triple Negative Breast Cancer
A Phase 1 study testing Radiation Therapy and Cisplatin in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.
Trial summary
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation Therapy and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2012to 8 Jun 2021
- Phase
- Phase 1
- 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
- Primary tumor is triple negative breast cancer
- Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins
- Pathologic or clinical stage II or III disease
- At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks)
Who cannot join
- Pregnant or breastfeeding
- Prior radiation to breast or ipsilateral regional nodes
- Ongoing therapy with other investigational agents
- Hormonal therapy
- Significant co-morbidity
- Pathologic complete response following preoperative chemotherapy
- Biopsy proven metastatic disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Dana-Farber at Milford
Milford, Massachusetts, 01757
Dana Farber at South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
Official title: A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy.
Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy
Read the detailed description
This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.
- Conditions
- Breast Cancer
- Being tested
- Radiation Therapy, Cisplatin
- Keywords
- Triple negative, Stage II, Stage III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Once daily, Monday - Friday for six weeks
CisplatinDrug
Also called CDDP
Intravenously, once weekly for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin + Radiation Therapy | Experimental | Cisplatin concurrently with radiation therapy Receives: Radiation: Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Cisplatin w/ Radiation
To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.
Measured: 2 years
Secondary outcomes (2)
Local recurrence at 5 years
To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.
Measured: 5 years
Long term toxicity
To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2018
- Study completion8 Jun 2021
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Bellon, Dana-Farber Cancer Institute
- Investigators
- Jennifer R Bellon, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674842
- Sponsor's protocol ID
- 12-283
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2012
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):45-52. doi: 10.1016/j.ijrobp.2021.03.002. Epub 2021 Mar 10.
PubMed 33713742
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01674842
- Acronym / sponsor ID
- 12-283
- Conditions
- Breast Cancer
- Keywords
- Triple negative, Stage II, Stage III
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2018 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 29 Aug 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.
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy.
Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy
Detailed description
This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin + Radiation Therapy | Experimental | Radiation: Radiation Therapy, Drug: CisplatinCisplatin concurrently with radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary tumor is triple negative breast cancer
- Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins
- Pathologic or clinical stage II or III disease
- At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks)
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding
- Prior radiation to breast or ipsilateral regional nodes
- Ongoing therapy with other investigational agents
- Hormonal therapy
- Significant co-morbidity
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 |
|---|---|---|
| Radiation TherapyOnce daily, Monday - Friday for six weeks | Radiation | Cisplatin + Radiation Therapy |
| CisplatinAlso: CDDPIntravenously, once weekly for six weeks | Drug | Cisplatin + Radiation Therapy |
Primary outcome
Safety of Cisplatin w/ Radiation
Time frame: 2 years
To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.
2 secondary outcomes
Local recurrence at 5 years
Time frame: 5 years
Long term toxicity
Time frame: 2 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 25 Aug 2021.
- Derived from this study: PubMed 33713742Bellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):45-52. doi: 10.1016/j.ijrobp.2021.03.002. Epub 2021 Mar 10.
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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.
Jennifer R Bellon, MD principal investigator
Dana-Farber Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiation Therapy and Cisplatin in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 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?
The sponsor lists 4 inclusion and 7 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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.
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?
Safety of Cisplatin w/ Radiation (time frame: 2 years). 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 NCT01674842, 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 25 Aug 2021.