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Feasibility of 3-D Conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage, Node Negative Breast Cancer Patients Using Acculoc Fiducial Markers: A Phase I Trial

Phase 1
45 Years
Not Enrolling
Breast Cancer

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Trial Information

Feasibility of 3-D Conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage, Node Negative Breast Cancer Patients Using Acculoc Fiducial Markers: A Phase I Trial



- To determine if the delivery of external-beam accelerated partial breast irradiation
(APBI) based on gold fiducial markers is more accurate when compared to the delivery of
radiotherapy based on bony anatomy in women with early-stage, node-negative breast


- To assess the migration of fiducial markers during a course of APBI.

- To quantify the change in the volume of the seroma (lumpectomy) cavity during a course
of APBI.

- To compare overall operative time for suturing fiducial markers into place vs current
standard method of placing surgical clips.

OUTLINE: Patients undergo planned lumpectomy with gold fiducial marker placement (if
procedure not already performed). Patients who meet the post lumpectomy criteria for
continue treatment in this study proceed to accelerated partial breast irradiation (APBI).
Between 15-80 days after surgery, patients undergo 3-dimensional APBI (may be
intensity-modulated radiotherapy) using CT-guided planning (with gold fiducial markers
placed at lumpectomy) once daily, 5 days a week, for 15 days.

Patients undergo fluoroscopy weekly to determine real-time movement of bony anatomy and
fiducial markers and cone-beam CT weekly to determine any change in volume of seroma cavity.

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed ductal carcinoma in situ or invasive carcinoma of the breast
(including ductal, medullary, papillary, colloid [mucinous], or tubular histologies)
meeting all of the following criteria:

- AJCC stage 0, I, or II (Tis, T1N0, or T2N0) disease with a lesion ≤ 3 cm treated
with lumpectomy and either sentinel node biopsy or axillary dissection (if
invasive carcinoma is present)

- Unifocal breast cancer (i.e., single focus that can be encompassed by one

- Underwent or plan to undergo lumpectomy with placement of gold fiducial markers
(markers placed concurrently with the surgery or on a later date)

- Patients who has underwent lumpectomy must meet all of the following criteria:

- Must be enrolled between 14-60 days from date of last surgery, and
radiation must start within 15-80 days of date of last surgery

- Four to six gold fiducial markers placed in the tumor bed, delineating the
margins of the lumpectomy cavity

- Negative, inked histologic margins of lumpectomy (> 1 mm) or re-excision
specimen to be confirmed prior to radiation

- Margins are unacceptable if there is invasive or non-invasive tumor
within 1 mm of the inked margin

- Negative post-excision mammography if malignancy-associated microcalcifications were
initially present

- Hormone receptor status not specified

Exclusion criteria:

- Evidence of suspicious microcalcifications in the breast prior to the start of

- One or more positive axillary nodes or positive sentinel biopsy

- Distant metastases

- Invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies
such as sarcoma or lymphoma

- Proven multicentric carcinoma (tumors in different quadrants of the breast or tumor
separated by at least 4 cm) with other clinically or radiographically suspicious
areas in the ipsilateral breast unless confirmed to be negative for malignancy by

- Palpable or radiographically suspicious contralateral axillary, supraclavicular,
infraclavicular, or internal mammary nodes, unless there is histologic confirmation
that these nodes are negative for tumor

- Paget's disease of the nipple

- Skin involvement, regardless of tumor size


- Female

- Menopausal status not specified

- ECOG performance status 0-1

- Life expectancy ≥ 2 years

- Not pregnant or nursing

- No prior treated breast carcinoma within the past 5 years

- No collagen vascular diseases, specifically systemic lupus erythematosus,
scleroderma, or dermatomyositis

- No co-existing medical conditions

- No patients with medical conditions that would preclude compliance with the trial, as
determined by the investigator

- No other malignancy, except non-melanomatous skin cancer, within the past 5 years

- Disease-free interval from any prior carcinoma must be continuous

- No breast technically unsuitable for radiotherapy


- See Disease Characteristics

- Concurrent tamoxifen citrate, anastrozole, or other hormonal therapy allowed

- Future chemotherapy allowed provided it is administered after the APBI and begins no
earlier than 2 weeks after completion of radiotherapy

- No tylectomies so extensive that the cosmetic result is low or poor prior to

- No prior radiation to the ipsilateral breast

- No prior non-hormonal therapy or radiotherapy for this disease

- No chemotherapy in the past 2 weeks

- No concurrent chemotherapy, immunotherapy, or experimental medications

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers

Outcome Time Frame:

During radiation therapy

Safety Issue:


Principal Investigator

Bruce G. Haffty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

July 2010

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • ductal breast carcinoma in situ
  • invasive ductal breast carcinoma
  • medullary ductal breast carcinoma with lymphocytic infiltrate
  • papillary ductal breast carcinoma
  • tubular ductal breast carcinoma
  • mucinous ductal breast carcinoma
  • breast cancer in situ
  • Breast Neoplasms



Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903