Trial Outcomes & Findings for External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks (NCT NCT01581619)

Last Updated: 2020-11-02

Results Overview

The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if \>10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI. 1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. 2. The development of clinical fat necrosis. 3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically. The data is shown as the number of participants that experienced each of the specific toxicities.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

2 years

Results posted on

2020-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Partial Breast Irradiation Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks
Overall Study STARTED	54
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Partial Breast Irradiation Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

The participant that withdrew consent was not included in the analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Partial Breast Irradiation n=54 Participants Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks
Age, Categorical <=18 years	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=54 Participants
Age, Categorical >=65 years	15 Participants n=54 Participants
Age, Continuous	62 years n=54 Participants
Sex: Female, Male Female	54 Participants n=54 Participants
Sex: Female, Male Male	0 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	1 Participants n=54 Participants
Race (NIH/OMB) White	51 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=54 Participants
Region of Enrollment United States	54 Participants n=54 Participants
Method of Initial Diagnosis Mammogram	51 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Method of Initial Diagnosis MRI ( magnetic resonance imaging)	1 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Method of Initial Diagnosis Other	1 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Side of the breast cancer Left Breast	27 Participants n=53 Participants • Participant that withdrew consent was not included
Side of the breast cancer Right Breast	26 Participants n=53 Participants • Participant that withdrew consent was not included
Stage Stage 0	8 Participants n=53 Participants • Participant that withdrew consent was not included
Stage Stage 1	45 Participants n=53 Participants • Participant that withdrew consent was not included
T staging Tis	8 Participants n=53 Participants • Participant that withdrew consent is not included
T staging T1a	17 Participants n=53 Participants • Participant that withdrew consent is not included
T staging T1b	22 Participants n=53 Participants • Participant that withdrew consent is not included
T staging T1c	6 Participants n=53 Participants • Participant that withdrew consent is not included
Her2 FISH Negative	40 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Her2 FISH Positive	1 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Her2 FISH Not Done	12 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Her2 IHC (3+) / Her2 Positive	1 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Her2 IHC (2+) / Borderline	4 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Her2 IHC (0, 1+) Her2 Negative	34 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Her2 IHC Not Done	14 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Estrogen Receptor Positive	53 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Estrogen Receptor Negative	0 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Progesterone Receptor Positive	47 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Progesterone Receptor Few/ Faint Cells	3 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Progesterone Receptor Negative	3 Participants n=53 Participants • The participant that withdrew consent was not included in the analysis
Histologic Grade Well Differentiated	21 Participants n=53 Participants • The participant that withdrew consent was not include in the analysis
Histologic Grade Moderately Differentiated	26 Participants n=53 Participants • The participant that withdrew consent was not include in the analysis
Histologic Grade Poorly Differentiated	1 Participants n=53 Participants • The participant that withdrew consent was not include in the analysis
Histologic Grade Other	5 Participants n=53 Participants • The participant that withdrew consent was not include in the analysis

PRIMARY outcome

Timeframe: 2 years

Population: Analysis does not include the one participant who withdrew consent before outcome was met.

Outcome measures

Outcome measures
Measure	Partial Breast Irradiation n=53 Participants Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks	Partial Breast Irradiation - Invasive Cancer Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks Participants with Invasive breast cancer
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks Grade 3 or 4 Skin/ Subcutaneous toxicity	0 Participants	—
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks Grade 3 or 4 Pulmonary Toxicity	0 Participants	—
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks Fat Necrosis	0 Participants	—
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks Rib fractures on ipsilateral treated side	0 Participants	—

SECONDARY outcome

Timeframe: 2 years

Population: The one participant that withdrew consent before the outcome was met was excluded from the analysis

The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.

Outcome measures

Outcome measures
Measure	Partial Breast Irradiation n=8 Participants Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks	Partial Breast Irradiation - Invasive Cancer n=45 Participants Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks Participants with Invasive breast cancer
Local Control Rates Local Control	8 Participants	45 Participants
Local Control Rates Local Recurrence	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: The one participant that withdrew consent before the outcome was met was excluded from the analysis

The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.

Outcome measures

Outcome measures
Measure	Partial Breast Irradiation n=53 Participants Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks	Partial Breast Irradiation - Invasive Cancer Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks Participants with Invasive breast cancer
Distant Control Rates Distant Control	53 Participants	—
Distant Control Rates Distant Metastasis	0 Participants	—

SECONDARY outcome

Timeframe: End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years

Population: The one participant that withdrew consent before outcomes were met was excluded from the analysis.

Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria. * Excellent: Little or no observable change * Good: Minimal but identifiable changes * Fair: Significant results of radiotherapy noted * Poor: Severe normal tissue sequelae

Outcome measures

Outcome measures
Measure	Partial Breast Irradiation n=53 Participants Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks	Partial Breast Irradiation - Invasive Cancer Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks Participants with Invasive breast cancer
Breast Cosmesis Excellent	39 Participants	—
Breast Cosmesis Good	12 Participants	—
Breast Cosmesis Fair	2 Participants	—
Breast Cosmesis Poor	0 Participants	—

Adverse Events

Partial Breast Irradiation

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Partial Breast Irradiation n=53 participants at risk Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks
Skin and subcutaneous tissue disorders Skin Infection	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Injury, poisoning and procedural complications Seroma	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.

Other adverse events

Other adverse events
Measure	Partial Breast Irradiation n=53 participants at risk Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks
Reproductive system and breast disorders Breast pain	13.2% 7/53 • Number of events 8 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Injury, poisoning and procedural complications Dermatitis radiation	64.2% 34/53 • Number of events 41 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Skin and subcutaneous tissue disorders Erythema multiforme	9.4% 5/53 • Number of events 6 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
General disorders Fatigue	35.8% 19/53 • Number of events 19 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	15.1% 8/53 • Number of events 9 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Vascular disorders Hot flashes	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
General disorders Localized edema	7.5% 4/53 • Number of events 5 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Gastrointestinal disorders Nausea	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
General disorders Non-cardiac chest pain	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
General disorders Pain	3.8% 2/53 • Number of events 2 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Skin and subcutaneous tissue disorders Pruritus	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	1.9% 1/53 • Number of events 1 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.8% 2/53 • Number of events 2 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	50.9% 27/53 • Number of events 31 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.
Skin and subcutaneous tissue disorders Skin induration	11.3% 6/53 • Number of events 6 • Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis.

Additional Information

Alphonse Taghian, MD, PhD

Massachusetts General Hospital

Phone: 617-726-7559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place