Ductal Breast Carcinoma in SituPhase 2NCT01100489
Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer
A Phase 2 study testing external beam radiation therapy, questionnaire administration and therapeutic conventional surgery in people with Ductal Breast Carcinoma in Situ and Estrogen Receptor-negative Breast Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ductal Breast Carcinoma in Situ, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer
- What is being tested?
- external beam radiation therapy, questionnaire administration and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Oct 2011
- 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 with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm)
- All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies
- A maximum of two radiographically detected malignant lesions
- Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =< 1 cm
- Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS
- Negative resection margins with at least a 2 mm margin from invasive and in-situ cancer or a negative re-excision
Show all 10Show fewer
- A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken
- Patients are eligible regardless of estrogen receptor, progesterone receptor, or Her-2/neu amplification
- Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy should be delivered first and radiation must begin no earlier than three weeks and no later than eight weeks following completion of chemotherapy
- Signed study-specific informed consent prior to study entry
Who cannot join
- Extensive intraductal component by the Harvard definition (i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue)
- Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
- Patients receiving neoadjuvant chemotherapy
- Patients with distant metastatic disease detected by radiographic imaging; specific studies for systemic imaging should be obtained as directed by localized symptoms or per available NCCN guidelines
- Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying the mutation by BRCAPRO (44) risk assessment >= 50%
- Diffuse calcifications throughout the breast
Show all 13Show fewer
- Patients with skin involvement or inflammatory breast cancer
- Patients with Paget's disease of the nipple
- Patients nonepithelial breast malignancies such as lymphoma or sarcoma
- Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis
- Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
- Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study
- Patients who are pregnant or lactating, due to potential fetal exposure to radiation and unknown effects of radiation on lactating females
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
UH-Chagrin Highlands
Orange, Ohio, 44122
UH-Westlake
Westlake, Ohio, 44145
About this study
Official title: A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.
II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.
SECONDARY OBJECTIVES:
- To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.
II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire.
III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy.
OUTLINE:
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.
- Conditions
- Ductal Breast Carcinoma in Situ, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Invasive Ductal Breast Carcinoma
- Being tested
- external beam radiation therapy, questionnaire administration, therapeutic conventional surgery
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Breast Neoplasms, Male, 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
External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
questionnaire administrationOther
Ancillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I).
therapeutic conventional surgeryProcedure or surgery
Patients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Receives: Radiation: external beam radiation therapy; Other: questionnaire administration; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral breast tumor recurrence rates
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
Measured: 5 years after completion of radiation
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
Measured: at 1 year after radiation
Secondary outcomes (3)
To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy
Measured: 5 years after completion of radiation treatment
Patient satisfaction with the procedure as determined by a questionnaire
Measured: at 1 year after radiation
To evaluate wound healing and overall complication rate after radiation
Measured: at one year after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Chen, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100489
- Sponsor's protocol ID
- CASE1109
- Other IDs
- NCI-2010-00644
- Status last verified
- Dec 2011
- First submitted
- 7 Apr 2010
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
- ClinicalTrials.gov ID
- NCT01100489
- Acronym / sponsor ID
- CASE1109
- Conditions
- Ductal Breast Carcinoma in Situ, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Invasive Ductal Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Apr 2010 (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: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.
II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.
SECONDARY OBJECTIVES:
- To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.
II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire.
III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy.
OUTLINE:
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: external beam radiation therapy, Other: questionnaire administration, Procedure: therapeutic conventional surgeryPatients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm)
- All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies
- A maximum of two radiographically detected malignant lesions
- Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =< 1 cm
- Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS
Key exclusion criteria (13 listed)
- Extensive intraductal component by the Harvard definition (i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue)
- Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
- Patients receiving neoadjuvant chemotherapy
- Patients with distant metastatic disease detected by radiographic imaging; specific studies for systemic imaging should be obtained as directed by localized symptoms or per available NCCN guidelines
- Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying the mutation by BRCAPRO (44) risk assessment >= 50%
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: EBRTExternal beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. | Radiation | Arm I |
| questionnaire administrationAncillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I). | Other | Arm I |
| therapeutic conventional surgeryPatients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities. | Procedure or surgery | Arm I |
Primary outcome
Ipsilateral breast tumor recurrence rates
Time frame: 5 years after completion of radiation
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
Time frame: at 1 year after radiation
3 secondary outcomes
To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy
Time frame: 5 years after completion of radiation treatment
Patient satisfaction with the procedure as determined by a questionnaire
Time frame: at 1 year after radiation
To evaluate wound healing and overall complication rate after radiation
Time frame: at one year after radiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Related InfoLink provided by the sponsor.
Related trials for Ductal Breast Carcinoma in Situ
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 2
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Ductal Carcinoma in Situ
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
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.
William Chen, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
3 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, questionnaire administration and therapeutic conventional surgery in people with Ductal Breast Carcinoma in Situ and Estrogen Receptor-negative Breast Cancer, run by Case Comprehensive Cancer Center at 3 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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ipsilateral breast tumor recurrence rates (time frame: 5 years after completion of radiation). 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 8 Dec 2011.