Ductal Breast CancerNCT00694577

Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer

A study testing Partial Breast Irradiation using 32 Gy / 8 fractions, Partial Breast Irradiation using 36 Gy / 9 fractions and Partial Breast Irradiation using 40 Gy /10 fractions in people with Ductal Breast Cancer, run by Massachusetts General Hospital at 4 sites 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 purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ductal Breast Cancer
What is being tested?: Partial Breast Irradiation using 32 Gy / 8 fractions, Partial Breast Irradiation using 36 Gy / 9 fractions and Partial Breast Irradiation using 40 Gy /10 fractions
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 324 participants
Where: 4 sitesUnited States
Study dates: Sep 2003to Jun 2021
Phase: Interventional
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT
18 years of age or older
ECOG Performance Status 0
Required laboratory data as outlined in the protocol

Who cannot join

Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
Tumor > 2.0cm, nodal involvement, or metastatic involvement
Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma
Known mutation carrier, including BRCA1 and BRCA2
History of cosmetic or reconstructive breast surgery

Show all 11Show fewer

Psychiatric illness which would prevent the patient from giving informed consent
Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
Participants with a "currently active" second malignancy other than non-melanoma skin cancers
Patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications
Women who are pregnant

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Massachusetts General Hospital
Boston, Massachusetts, 02214

Other trials in United States

About this study

Official title: Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study

The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.

Read the detailed description

In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation".
Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments.
Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy.
We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial.
Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.

Conditions: Ductal Breast Cancer
Being tested: Partial Breast Irradiation using 32 Gy / 8 fractions, Partial Breast Irradiation using 36 Gy / 9 fractions, Partial Breast Irradiation using 40 Gy /10 fractions
Keywords: non-invasive breast cancer, early invasive breast cancer, radiation, PBI
Medical subject headings: Carcinoma, Ductal, Breast

What participants receive

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

Partial Breast Irradiation using 32 Gy / 8 fractionsRadiation
Also called PBI
32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractionsRadiation
Also called PBI
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractionsRadiation
Also called PBI
40 Gy-10 Treatments, 5 Treatment days

Study groups in NCT00694577
Study group	Role	What they receive
Irradiation using 32 Gy / 8 fractions	Experimental	Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week Receives: Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions; Radiation: Partial Breast Irradiation using 40 Gy /10 fractions
Irradiation using 36 Gy / 9 fractions	Experimental	Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week Receives: Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions; Radiation: Partial Breast Irradiation using 40 Gy /10 fractions
Irradiation using 40 Gy / 10 fractions	Experimental	Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week Receives: Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions; Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions; Radiation: Partial Breast Irradiation using 40 Gy /10 fractions

What is being measured

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

Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility.
Measured: 10 years
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy
Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy
Measured: 10 years

Secondary outcomes (4)

Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint
Number of patients who presented with moderate to severe composite toxicity as an endpoint
Measured: 8 years
Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation
Rate of moderate to severe breast fibrosis determined by number of patients who developed moderate to severe breast fibrosis after partial breast irradiation according to radiation dose level
Measured: 8 years
Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation
Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes.
Measured: 8 years
To Evaluate Patient Satisfaction
A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance.
Measured: 8 years

Timeline

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

Sep 2003Jun 2021

First posted10 Jun 2008 (estimated)
Study startSep 2003
Primary completionJun 2021
Study completionJun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Ductal Breast CancerStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00694577
Sponsor's protocol ID: 03-179
Status last verified: Oct 2022
First submitted: 6 Jun 2008
Last updated: 14 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Pashtan IM, Recht A, Ancukiewicz M, Brachtel E, Abi-Raad RF, D'Alessandro HA, Levy A, Wo JY, Hirsch AE, Kachnic LA, Goldberg S, Specht M, Gadd M, Smith BL, Powell SN, Taghian AG. External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e271-7. doi: 10.1016/j.ijrobp.2012.04.019. Epub 2012 May 30.
PubMed 22652104
Recht A, Ancukiewicz M, Alm El-Din MA, Lu XQ, Martin C, Berman SM, Hirsch AE, Kachnic LA, Katz A, MacDonald S, Nedea EA, Stevenson MA, Powell SN, Taghian AG. Lung dose-volume parameters and the risk of pneumonitis for patients treated with accelerated partial-breast irradiation using three-dimensional conformal radiotherapy. J Clin Oncol. 2009 Aug 20;27(24):3887-93. doi: 10.1200/JCO.2008.20.0121. Epub 2009 Jul 20.
PubMed 19620489

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ductal Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
ClinicalTrials.gov ID: NCT00694577
Acronym / sponsor ID: 03-179
Conditions: Ductal Breast Cancer
Keywords: non-invasive breast cancer, early invasive breast cancer, radiation, PBI
Study type: Interventional
Recruitment status: Completed
Enrolment: 324 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Boston Medical Center
Study start: Sep 2003
Primary completion: Jun 2021 (actual)
Study completion: Jun 2021 (actual)
First posted: 10 Jun 2008 (estimated)
Results: Posted 14 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.

Detailed description

In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation".
Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments.
Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy.
We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial.
Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Irradiation using 32 Gy / 8 fractions	Experimental	Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions, Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions, Radiation: Partial Breast Irradiation using 40 Gy /10 fractionsStudy Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Irradiation using 36 Gy / 9 fractions	Experimental	Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions, Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions, Radiation: Partial Breast Irradiation using 40 Gy /10 fractionsStudy Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Irradiation using 40 Gy / 10 fractions	Experimental	Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions, Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions, Radiation: Partial Breast Irradiation using 40 Gy /10 fractionsStudy Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT
18 years of age or older
ECOG Performance Status 0
Required laboratory data as outlined in the protocol

Key exclusion criteria (11 listed)

Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
Tumor > 2.0cm, nodal involvement, or metastatic involvement
Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma
Known mutation carrier, including BRCA1 and BRCA2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Partial Breast Irradiation using 32 Gy / 8 fractionsAlso: PBI32 Gy-8 Treatments, 4 Treatment Days	Radiation	Irradiation using 32 Gy / 8 fractions, Irradiation using 36 Gy / 9 fractions, Irradiation using 40 Gy / 10 fractions
Partial Breast Irradiation using 36 Gy / 9 fractionsAlso: PBI36 Gy- 9 Treatments, 4 1/2 Treatment Days	Radiation	Irradiation using 32 Gy / 8 fractions, Irradiation using 36 Gy / 9 fractions, Irradiation using 40 Gy / 10 fractions
Partial Breast Irradiation using 40 Gy /10 fractionsAlso: PBI40 Gy-10 Treatments, 5 Treatment days	Radiation	Irradiation using 32 Gy / 8 fractions, Irradiation using 36 Gy / 9 fractions, Irradiation using 40 Gy / 10 fractions

Primary outcome

Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
Time frame: 10 years
Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility.
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy
Time frame: 10 years
Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy

4 secondary outcomes

Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint
Time frame: 8 years
Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation
Time frame: 8 years
Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation
Time frame: 8 years
To Evaluate Patient Satisfaction
Time frame: 8 years

Results and safety

Results posted to the registry on 14 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Irradiation Using 32 Gy / 8 Fractions	99	98
Irradiation Using 36 Gy / 9 Fractions	101	101
Irradiation Using 40 Gy / 10 Fractions	124	124

Primary outcome: Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.

Time frame: 10 years. Count of participants. Unit: Participants

Measure	Group 1 n = 98	Group 2 n = 101	Group 3 n = 124
Value	98	101	124

Primary outcome: Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy

Time frame: 10 years. Count of participants. Unit: Participants

Measure	Group 1 n = 98	Group 2 n = 101	Group 3 n = 124
Value	6	4	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 98 (0%)	0 of 98 (0%)	0 of 98
Group 2	0 of 99 (0%)	0 of 99 (0%)	0 of 99
Group 3	0 of 124 (0%)	0 of 124 (0%)	0 of 124

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22652104Pashtan IM, Recht A, Ancukiewicz M, Brachtel E, Abi-Raad RF, D'Alessandro HA, Levy A, Wo JY, Hirsch AE, Kachnic LA, Goldberg S, Specht M, Gadd M, Smith BL, Powell SN, Taghian AG. External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e271-7. doi: 10.1016/j.ijrobp.2012.04.019. Epub 2012 May 30.
Derived from this study: PubMed 19620489Recht A, Ancukiewicz M, Alm El-Din MA, Lu XQ, Martin C, Berman SM, Hirsch AE, Kachnic LA, Katz A, MacDonald S, Nedea EA, Stevenson MA, Powell SN, Taghian AG. Lung dose-volume parameters and the risk of pneumonitis for patients treated with accelerated partial-breast irradiation using three-dimensional conformal radiotherapy. J Clin Oncol. 2009 Aug 20;27(24):3887-93. doi: 10.1200/JCO.2008.20.0121. Epub 2009 Jul 20.
Individual participant dataSharing planned: No

Related trials for Ductal Breast Cancer

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alphonse Taghian, MD, PhD principal investigator

Massachusetts General Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2022). 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 Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion. (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT00694577, which also lists 2 linked publications.

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 14 Nov 2022.