RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether radiation to part of the breast over 3 days is safe and causes few or mild side effects. It is for women with newly diagnosed breast cancer or DCIS (cancer cells inside the milk ducts) who have had a lumpectomy, surgery to remove the cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The main study is for women age 45 or older with one area of early-stage ductal breast cancer or DCIS smaller than 3 cm, with no spread to lymph nodes or distant body parts.
  • Some women may qualify without lymph node surgery: those age 70 or older with a small, estrogen-sensitive tumor, or those age 50 or older with a hormone-sensitive tumor no larger than 2 cm. Their lymph nodes must show no signs of cancer on the required checks.
  • The main study requires no cancer at the edge of the removed tissue, or no cancer in the final tissue removed during repeat surgery.
  • You must be fully active or able to walk and do light work. You must sign a consent form and be able to follow study rules.
  • If you can become pregnant, you need a negative blood pregnancy test within 14 days before treatment. During the study, use two birth control methods or avoid sex that could cause pregnancy. Tell your doctor right away if you become pregnant.
  • A separate medium-risk study group may accept women who had chemotherapy before surgery. Before chemotherapy, the tumor must be no larger than 5 cm, with no or limited lymph node spread. After treatment, there must be no lymph node cancer and no invasive tumor larger than 2 cm.
  • Other ways to qualify for the medium-risk group include an Oncotype score of 26 or higher or a high PAM50 score (tumor risk tests); limited cancer in blood or lymph vessels; lobular cancer, which starts in milk-making glands; or cancer less than 1 mm from the removed tissue's edge.
  • Women ages 40–49 may qualify for the medium-risk group if they have no past noncancerous breast biopsies, no past or current abnormal breast cells or LCIS (abnormal cells in milk-making glands), and no parent, sibling, or child with breast cancer.

Who can't join

  • Cancer has spread to distant body parts, or there are multiple separate breast tumors. Tiny separate areas may be allowed after study review. Widespread suspicious calcium spots in the breast also rule out joining.
  • You are pregnant, breastfeeding, or plan to become pregnant from screening through 180 days after the last study treatment.
  • You have had radiation to either breast or the chest, or cosmetic or reconstructive breast surgery.
  • There is extensive cancer in blood or lymph vessels, or a large amount of cancer inside the milk ducts both within and beyond the main tumor.
  • Testing shows a BRCA1, BRCA2, or other gene mutation. Genetic testing is not required to join.
  • Your doctor believes a health problem makes treatment too risky, such as an uncontrolled infection, uncontrolled diabetes, or a connective tissue disease such as lupus. Most other currently active cancers also rule out joining, except non-melanoma skin cancer.
  • You are in, or plan to join, another study of whole-body drug treatment after breast cancer surgery, or you are receiving another experimental drug.
  • You are receiving other cancer treatment during study radiation, or have not finished it at least 2 weeks before radiation and recovered from its short-term side effects. Hormone therapy, anti-HER2 drugs, and bisphosphonate bone drugs are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. Patients age 50 or older who are clinically node-negative by physical exam and ultrasound and have a primary tumor that is \<=2 cm and hormone-receptor positive, are also eligible. * Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen. * ECOG Performance Status of 0 or 1. * 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-T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0-N1 (on exam and imaging) with pathological ypT0, ypTis, or ypT1 (\<=2cm) and ypN0 (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 * Surgical margins less than 1 mm to invasive or in-situ disease. 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.

Study sites (9)

CT

FL

NJ

NY