Inflammatory Breast CancerPhase 2NCT01417286
Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
A Phase 2 study testing External beam radiation therapy in people with Inflammatory Breast Cancer and Invasive Ductal Breast Carcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma
- What is being tested?
- External beam radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2010to 20 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
- American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3, T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (T4d) is allowed
- Patients with locally advanced breast cancer on clinical exam and diagnostics ( > 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed
- Multifocal/multicentric disease is allowed
- Negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin
- Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician
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- Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy; neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after mastectomy or after any adjuvant chemotherapy as described above
- Chest wall reconstruction is allowed
- The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
- Signed study-specific informed consent form prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Patient with distant metastases (M1)
- Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
- Patient with T1N0 or T2N0 disease
- Prior radiation therapy to the chest
- Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- Patients with co-existing medical conditions with life expectancy < 2 years
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- Patients with psychiatric (with the possible exception of incompetence as defined by New Jersey [NJ] law) or addictive disorders that would preclude obtaining informed consent
- Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
- Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females
- Women who are able to conceive and unwilling to practice an effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Huntsman Cancer Hospital
Salt Lake City, Utah, 84103
About this study
Official title: Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
Read the detailed description
PRIMARY OBJECTIVES:
- Freedom from local failure and freedom from regional failure.
SECONDARY OBJECTIVES:
- Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.
III. To correlate toxicity, cosmesis, and local control with molecular markers.
OUTLINE:
Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.
- Conditions
- Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Mucinous Ductal Breast Carcinoma, Papillary Ductal Breast Carcinoma, Stage II Breast Cancer
- Being tested
- External beam radiation therapy
- Medical subject headings
- Inflammatory Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiation therapyRadiation
Also called EBRT
Hypofractionated accelerated radiation therapy over 11 days
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Radiation: External beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Local, Regional, and/or Distant Failure
Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.
Measured: Up to 5 years after dose of last treatment, an average of 62 months
Secondary outcomes (2)
Count of Participants With Grade Three or Higher Toxicities
Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
Measured: weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications
Measured: Up to five years after dose of last treatment, an average of 62 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study start21 Dec 2010
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Bruce G Haffty, Rutgers, The State University of New Jersey
- Investigators
- Bruce Haffty, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417286
- Sponsor's protocol ID
- 041001
- Other IDs
- NCI-2011-01124, P30CA072720, 0220100204
- Status last verified
- Mar 2023
- First submitted
- 2 Aug 2011
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT01417286
- Acronym / sponsor ID
- 041001
- Conditions
- Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Mucinous Ductal Breast Carcinoma, Papillary Ductal Breast Carcinoma, Stage II Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- 21 Dec 2010 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
Detailed description
PRIMARY OBJECTIVES:
- Freedom from local failure and freedom from regional failure.
SECONDARY OBJECTIVES:
- Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.
III. To correlate toxicity, cosmesis, and local control with molecular markers.
OUTLINE:
Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: External beam radiation therapyPatients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
- American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3, T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive carcinoma of the breast treated with mastectomy and either sentinel node biopsy or axillary dissection; inflammatory carcinoma (T4d) is allowed
- Patients with locally advanced breast cancer on clinical exam and diagnostics ( > 3 cm and/or clinically node-positive) who have mastectomy after induction chemotherapy are allowed
- Multifocal/multicentric disease is allowed
- Negative inked histologic margins of mastectomy (no invasive cells at margin) or positive margin at pectoralis fascia or skin
Key exclusion criteria (10 listed)
- Patient with distant metastases (M1)
- Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
- Patient with T1N0 or T2N0 disease
- Prior radiation therapy to the chest
- Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
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 |
|---|---|---|
| External beam radiation therapyAlso: EBRTHypofractionated accelerated radiation therapy over 11 days | Radiation | Radiation Therapy |
Primary outcome
Number of Participants With Local, Regional, and/or Distant Failure
Time frame: Up to 5 years after dose of last treatment, an average of 62 months
Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.
2 secondary outcomes
Count of Participants With Grade Three or Higher Toxicities
Time frame: weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications
Time frame: Up to five years after dose of last treatment, an average of 62 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Bruce Haffty, MD principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing External beam radiation therapy in people with Inflammatory Breast Cancer and Invasive Ductal Breast Carcinoma, run by Rutgers, The State University of New Jersey 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?
The sponsor lists 11 inclusion and 10 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 20 Apr 2023. 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 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?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Local, Regional, and/or Distant Failure (time frame: Up to 5 years after dose of last treatment, an average of 62 months). 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 20 Apr 2023.