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A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer


Inclusion Criteria:



- Female

- Age ≥ 18 years

- Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS
measuring <2 cm on pathology and/or mammogram that is histologically confirmed at
MSKCC

- Histologically negative tumor margin 2 mm or more from any inked edges or no tumor in
a re-excision specimen or final shaved specimen

- ECOG Performance Status of 0 or 1

- Granulocytes ≥1,500/μl and platelet count must be ≥100,000/μl at the beginning of
therapy for patients treated with adjuvant chemotherapy

- 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 evaluation are eligible if patient will take hormonal therapy.

- Patients with T1N0(i+) tumors on sentinel 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.

- 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.

Exclusion Criteria:

- Patients with distant metastasis.

- Patients who are pregnant or breastfeeding.

- Patients with diffuse (>1 quadrant or >5 cm) suspicious microcalcifications.

- Prior radiation therapy to the ipsilateral or contralateral breast or thorax.

- Histological evidence of lymphovascular invasion (LVI). Cases termed focally
suspicious for LVI but where no definitive LVI is found are eligible.

- Histologic evidence of EIC, defined as the presence of intraductal carcinoma both
within the primary infiltrating ductal tumor (comprising at least 25% of the tumor
area) and intraductal carcinoma present clearly beyond the edges of the invasive
tumor, or as a predominantly intraductal tumor with one or more areas of focal
invasion.

- Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests
in order to enroll on the study. However, 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 not receive additional RT and the patient will be replaced in the trial.

- History of cosmetic or reconstructive breast surgery.

- Psychiatric illness that would prevent the patient from giving informed consent.

- Patients for whom the delivery of PBI is not feasible

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of PBI-directed external-beam radiation therapy

Outcome Description:

In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks.

Outcome Time Frame:

Two weeks

Safety Issue:

Yes

Principal Investigator

Simon Powell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-114

NCT ID:

NCT01203839

Start Date:

September 2010

Completion Date:

September 2014

Related Keywords:

  • Breast Cancer
  • stage 1 breast cancer
  • invasive ductal breast
  • Partial Breast Irradiation (PBI)
  • radiation
  • 10-114
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York