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Stage IA-IIA Breast CancerPhase 1/2NCT01839838

APBI Proton Feasibility and Phase II Study

A Phase 1/2 study testing Proton Therapy in people with Stage IA-IIA Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Stage IA-IIA Breast Cancer
What is being tested?
Proton Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
22 Apr 2013to 23 Dec 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of invasive or non-invasive breast cancer.
  • Invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies.
  • AJCC T1 or T2; N0 or N1mic; Stage IA-IIA breast cancer or AJCC TIS (Stage 0) ductal carcinoma in situ without invasion
  • Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathological size is 3 cm or less).
  • Estrogen and/or progesterone receptor positive invasive breast cancer. DCIS stage 0 does not require receptor testing.
  • No evidence of distant metastatic disease as documented by history and physical examination (radiographic staging only to be performed as indicated by symptoms or physical findings.)
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  • Patients must have an ECOG Performance Status of 0, 1 or 2
  • Age ≥ 50.
  • Patients must be able to provide informed consent.
  • Patients must have undergone breast-conserving surgery
  • All tumors (invasive and non-invasive disease) must be excised with a minimum margin width of ≥ 2 mm. Re-excision of surgical margins is permitted. Focally close (<2 mm) or positive (tumor cells at the inked edge of the specimen) margins determined to be at an anatomic boundary of resection by the surgeon, such as posterior fascia for posterior margins or skin for anterior margins, are also acceptable.
  • Patients with invasive breast cancer must be node-negative (N0) or have only microscopic disease (≤2mm) in the nodes (N1mi). Patients with Stage IA - IIA are required to have axillary staging but it will not be done for patients with Stage 0 DCIS. Options for axillary staging include:
  • Negative sentinel lymph node biopsy (SLNB)
  • Level I-II axillary lymph node dissection (ALND) (6 or more nodes removed).
  • Positive SLNB followed by completion ALND (6 or more nodes removed).
  • Patients presenting with abnormal microcalcifications on a screening mammogram must have radiographically confirmed excision of the suspicious microcalcifications, either by specimen radiograph or post-biopsy mammograms.
  • The patient must be enrolled on the study within 50 days following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
  • The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the postoperative/pre-enrollment CT scan.
  • Patients must have bilateral mammogram and/or breast MRI within 3 months of diagnosis of their breast cancer.
  • CBC/differential obtained within 3 months prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 75,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
  • Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields. Both sides may be treated with APBI if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with APBI if the criteria are met for only one tumor.
  • Patients with a history of prior breast cancer in the opposite breast are eligible as long as treatment can be performed without overlapping any prior RT fields.
  • Patients with a history of prior breast cancer in the ipsilateral breast treated with lumpectomy alone (no RT) are eligible as long as the other entry criteria for this study are met.
  • Patients with a history of non-breast malignancies are eligible as long as they have not received prior radiotherapy to the thoracic region, and have a greater than 2 year interval without evidence of recurrence.
  • Women of childbearing potential must be non-pregnant and non-lactating and willing to exercise an effective form of birth control during radiation therapy (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
  • Patient must provide study-specific informed consent prior to study entry.

Who cannot join

  • Male breast cancer
  • T2 (>3cm), T3, T4, Node positive (other than N1mi), or M1 disease
  • Lobular or mixed ductal and lobular histology.
  • Multifocal primary tumor.
  • Clear delineation of the extent of the lumpectomy cavity is not possible. Prior or simultaneous malignancies within the past two years (other than carcinoma in situ of the cervix, CIS of the colon, melanoma in situ, thyroid cancer, and basal cell or squamous cell carcinoma of the skin).
  • Any non-axillary sentinel node(s) positive. (Note that intramammary nodes are staged as axillary nodes).
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  • Patients who have had a positive SLNB but decline completion ALND are not eligible.
  • Patients treated with neoadjuvant chemotherapy are not eligible.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histological confirmation that these nodes are negative for tumor.
  • Suspicious microcalcifications, densities, or palpable abnormalities (in the inpsilateral or contralateral breast) unless these were biopsied and found to be benign.
  • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or two or more breast cancers not resectable through a single lumpectomy incision.
  • Paget's disease of the nipple.
  • Surgical margins that cannot be microscopically assessed or are positive at pathological evaluation. A focally positive margin determined to be at an anatomic boundary of resection by the surgeon, such as posterior fascia for posterior margins and skin for anterior margins, is also acceptable. If surgical margins are rendered free of disease by re-excision, the patient is eligible.
  • Breast implants. (Patients who have implants removed are eligible).
  • Prior ipsilateral breast or thoracic radiation for any condition.
  • Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnant women, women planning to become pregnant and women that are nursing.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Actively being treated on any other therapeutic research study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Feasibility And Phase Ii Trial Of Accelerated Partial Breast Irradiation Using Proton Therapy For Women With Stage IA-IIA Breast Cancer

The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.

Read the detailed description

The purpose of the APBI Proton Therapy study is to examine the feasibility, side effects, and clinical efficacy of using proton therapy on only the tumor bed of women being treated for breast cancer after surgical removal of malignancy (as opposed to whole breast treatment). The study's aim is to establish the effects of this type of therapy as it compares to both traditional radiation and whole breast treatment therapies. In order to be eligible, the patient must be a female older than 50 with either invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies of stage IA-IIA breast cancer, ECOG performance status of 0-2, have margins of greater than or equal to 2mm, be node negative or have only microscopic node disease, have estrogen- or progesterone-positive breast cancer, and other eligibility criteria must be met that is more detailed to describe herein.

Being tested
Proton Therapy
Keywords
Women, age 50 and above, with, that has been, surgically excised

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton TherapyRadiation

Study groups in NCT01839838
Study groupRoleWhat they receive
APBI with protons Phase 1ExperimentalFeasibility phase 1
Receives: Radiation: Proton Therapy
APBI with protons Phase 2ExperimentalStudy phase 2
Receives: Radiation: Proton Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons

    Number of Participants that meets the criteria of feasibility and acute toxicity will be reported. The objectives were both feasibility and acute toxicity profile of accelerated partial breast radiation using protons. Feasibility was based on multiple radiation planning and treatment parameters: (1) a patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised; (2) a patient is unable to tolerate more than 20% of treatments using proton RT (ie, >2 of the 10 fractions); and/or (3) a patient is unable to complete all treatment within 5 days of the estimated date of treatment completion or requires a treatment break of greater than 5 days. A feasibility rate >90% was needed to proceed to the phase 2 portion.

    Outcomes measured and reported were: late toxicity was "% of participants with grade 3 or higher late toxicity"

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study start22 Apr 2013
  3. Primary completion23 Dec 2022
  4. Study completion23 Dec 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839838
Sponsor's protocol ID
UPCC 04113
Status last verified
Oct 2024
First submitted
23 Apr 2013
Last updated
7 Nov 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Proton Therapy in people with Stage IA-IIA Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site 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 26 inclusion and 19 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: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839838.

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 7 Nov 2024.

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