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Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT04084730
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE September 4, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE August 30, 2019
Estimated Primary Completion Date August 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
Toxicity with novel APBI schedule as determined by CTCAE version 5 [ Time Frame: 24 months ]
The study is deemed too toxic if the rate of serious toxicity is >/= 10%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
Official Title  ICMJE Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts
Brief Summary The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Invasive Ductal Breast Carcinoma
  • Invasive Ductal Carcinoma, Breast
  • DCIS
  • DCIS Grade 1
  • DCIS Grade 2
  • Breast Cancer
Intervention  ICMJE Radiation: Accelerated Partial Breast Irradiation
Treatment will consist of APBI delivered using external beam RT techniques to a dose of 24 Gy in 3 fractions of 8.0 Gy delivered on consecutive weekdays
Other Name: APBI
Study Arms  ICMJE Experimental: Participants with Breast Cancer
Participants will have unicentric pathological stage I invasive ductal breast cancer or Grade 1 or 2 DCIS measuring <3cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC.
Intervention: Radiation: Accelerated Partial Breast Irradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2023
Estimated Primary Completion Date August 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • Age >/= 45 years
  • Unicentric pathological stage I (pT1 or T2 pN0_M0) invasive ductal breast cancer or DCIS measuring <3 cm in longest diameter on pathology and/or mammogram that is histologically confirmed. If T2, the tumor must be less than 3cm in longest diameter. Note: Women ≥ 70 years or older with T1 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically negative axillary nodes, and do not undergo surgical lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible
  • Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen.
  • ECOG Performance Status of 0 or 1.
  • Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery.
  • Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
  • Written informed consent obtained from subject and ability for subject or comply with the requirements of the study
  • Female subjects of childbearing potential should be willing to use 2 methods or birth control or be surgically sterile or abstain from heterosexual activity for the duration of study participation. Should a woman become pregnant while participating on study, she should inform the treating physician immediately.

Inclusion Criteria for intermediate risk substudy:

  • Post-NAC cohort patients: clinical T1 or T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0 (on exam and imaging) with pathological pT0 or pTis and pN0 (any regimen of neoadjuvant chemotherapy agents is allowed)

OR

  • Oncotype RS score of 26 or higher

OR

  • PAM50 ROR scored as "HIGH"

OR

  • Presence or LVI (focal, limited or "not otherwise specified") in the lumpectomy specimen

OR

  • Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant or prior LCIS in either breast, 4) no family history of breast cancer in first degree relatives)

OR

  • Invasive lobular carcinoma

OR

  • Women 70 or older with tumors 2.0 cm or less in size and with clinically or pathologically negative nodes who decline or are ineligible for hormonal therapy OR discontinue hormonal therapy within 3 months of initiating treatment.

Exclusion Criteria:

  • Patients with distant metastasis
  • Patients who are pregnant or breastfeeding
  • Patients with diffuse (>1 quadrant or >5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and/or appear multifocal due to sectioning is allowed after review with PI).
  • Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
  • Histological evidence of extensive lymphovascular invasion (LVI)
  • Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor.
  • Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. Note: in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare/unlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu-negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will be given the option of remaining on the breast conservation paradigm or opting for mastectomy (as is done in this rare scenario is standard of care practice). The patient will be replaced on the trial.
  • History of cosmetic or reconstructive breast surgery.
  • Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 3 years.
  • Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer
  • Expecting to conceive within the projected duration of the trials, starting with screening visit through 180 days after the last dose of trial treatment
  • Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosponates are permitted without restriction even during protocol treatment. Note: This does not apply to hormonal therapies such as tamoxifen or AIs, which are permitted. This does not apply to anti-Her2 therapies such as trastuzumab or TDM-1, which are also permitted.
  • Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Atif J Khan, MD 848-225-6334 khana7@mskcc.org
Contact: Simon Powell, MD, PhD 212-639-3639 powells@mskcc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04084730
Other Study ID Numbers  ICMJE 19-300
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Atif J Khan, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP