Trial Outcomes & Findings for Partial Breast Irradiation With Chemotherapy (NCT NCT00278109)

NCT ID: NCT00278109

Last Updated: 2020-02-19

Results Overview

Number of participants with Grade 4 toxicity as defined by the following criteria: Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture \>10% linear reduction; 4= Necrosis

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: up to 5 years
• Results posted on: 2020-02-19

Participant Flow

Two patients did not initiate study procedures: one was found to have residual gross disease during treatment planning, and another withdrew consent.

Participant milestones

Measure	Experimental cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy
Overall Study STARTED	25
Overall Study Completed 3 Cycles of Chemotherapy	25
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Experimental cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy
Overall Study Adverse Event	3
Overall Study social circumstances	1

Baseline Characteristics

Partial Breast Irradiation With Chemotherapy

Baseline characteristics by cohort

Measure	Experimental n=25 Participants cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy
Age, Customized Age <= 45 years	5 Participants n=5 Participants
Age, Customized Age >= 45 years	20 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: Data was only collected on participants who completed the study.

Number of participants with Grade 4 toxicity as defined by the following criteria:

Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= Necrosis

Outcome measures

Measure	Experimental n=25 Participants cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy
Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity	0 Participants

Adverse Events

Experimental

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental n=25 participants at risk cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy
Blood and lymphatic system disorders Neutropenia	4.0% 1/25 • Number of events 1 • Weekly then monthly then annually for up to 5 years.

Other adverse events

Measure	Experimental n=25 participants at risk cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy
Skin and subcutaneous tissue disorders perianal dermatitis	4.0% 1/25 • Number of events 1 • Weekly then monthly then annually for up to 5 years.
Skin and subcutaneous tissue disorders foot blisters	4.0% 1/25 • Number of events 1 • Weekly then monthly then annually for up to 5 years.
Respiratory, thoracic and mediastinal disorders cough/bronchospasms	4.0% 1/25 • Number of events 1 • Weekly then monthly then annually for up to 5 years.
Blood and lymphatic system disorders Absolute neutrophil count	16.0% 4/25 • Number of events 4 • Weekly then monthly then annually for up to 5 years.
Gastrointestinal disorders Nausea & vomiting	12.0% 3/25 • Number of events 3 • Weekly then monthly then annually for up to 5 years.
Immune system disorders Mucositis	8.0% 2/25 • Number of events 2 • Weekly then monthly then annually for up to 5 years.
General disorders Fatigue	4.0% 1/25 • Number of events 1 • Weekly then monthly then annually for up to 5 years.
Infections and infestations Contralateral breast abscess	4.0% 1/25 • Number of events 1 • Weekly then monthly then annually for up to 5 years.
Skin and subcutaneous tissue disorders Grade 1 Radiation Dermatitis	84.0% 21/25 • Number of events 21 • Weekly then monthly then annually for up to 5 years.

Additional Information

Richard Zellars MD

Indiana University School of Medicine

Phone: 3179444505

Email: rzellars@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place