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Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery (IMPORT)

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IA breast cancer, stage II breast cancer, invasive ductal breast carcinoma, invasive ductal breast carcinoma with predominant intraductal component

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of low-risk early stage breast cancer, meeting the following criteria:
- Invasive adenocarcinoma
  - No invasive carcinoma of classical lobular type
  - lympho-vascular invasion present or absent
- Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
- Unifocal disease
- Grade I, II, or III disease
- Axillary lymph nodes negative or 1-3 nodes positive (pN0 or pN+(1-3))
Must have undergone breast conservation surgery with or without adjuvant systemic therapy
- Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
No prior mastectomy
No blood-borne metastases

PATIENT CHARACTERISTICS:

No prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior endocrine therapy or chemotherapy
- Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
- No primary endocrine therapy as a replacement for surgery
No concurrent chemoradiotherapy

Sites / Locations

Royal Marsden - Surrey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (control)

Arm II

Arm III

Arm Description

Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.

Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.

Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.

Outcomes

Primary Outcome Measures

Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment

Secondary Outcome Measures

Location of tumor relapse

Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment

Regional and distant metastases

Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments

Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years

Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years

Full Information

NCT ID

NCT00814567

First Posted

December 24, 2008

Last Updated

February 26, 2019

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Cancer Research UK

1. Study Identification

Unique Protocol Identification Number

NCT00814567

Brief Title

Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery

Acronym

IMPORT

Official Title

Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 3, 2007 (Actual)

Primary Completion Date

June 15, 2016 (Actual)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Cancer Research UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.

Detailed Description

OBJECTIVES: To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer. OUTLINE: This is a multicenter study. Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms. Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks. Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks. Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks. All patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays. Patients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years. After completion of study treatment, patients are followed for 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

recurrent breast cancer, stage IA breast cancer, stage II breast cancer, invasive ductal breast carcinoma, invasive ductal breast carcinoma with predominant intraductal component

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2018 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (control)

Arm Type

Active Comparator

Arm Description

Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.

Arm Title

Arm III

Arm Type

Experimental

Arm Description

Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy

Primary Outcome Measure Information:

Title

Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Location of tumor relapse

Time Frame

5 years

Title

Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment

Time Frame

5 years

Title

Regional and distant metastases

Time Frame

5 years

Title

Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments

Time Frame

5 years

Title

Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years

Time Frame

5 years

Title

Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years

Time Frame

10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of low-risk early stage breast cancer, meeting the following criteria: Invasive adenocarcinoma No invasive carcinoma of classical lobular type lympho-vascular invasion present or absent Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component) Unifocal disease Grade I, II, or III disease Axillary lymph nodes negative or 1-3 nodes positive (pN0 or pN+(1-3)) Must have undergone breast conservation surgery with or without adjuvant systemic therapy Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia) At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence) No prior mastectomy No blood-borne metastases PATIENT CHARACTERISTICS: No prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior endocrine therapy or chemotherapy Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met No primary endocrine therapy as a replacement for surgery No concurrent chemoradiotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charlotte E Coles, PhD

Organizational Affiliation

University of Cambrige, England

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Marsden - Surrey

City

Sutton

State/Province

England

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28779963

Citation

Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.

Results Reference

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PubMed Identifier

30532984

Citation

Bhattacharya IS, Haviland JS, Kirby AM, Kirwan CC, Hopwood P, Yarnold JR, Bliss JM, Coles CE; IMPORT Trialists. Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial. J Clin Oncol. 2019 Feb 1;37(4):305-317. doi: 10.1200/JCO.18.00982. Epub 2018 Dec 11.

Results Reference

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PubMed Identifier

30236641

Citation

Kirby AM, Bhattacharya IS, Wilcox M, Haviland JS. The IMPORT LOW Trial: Collaborative Research Accelerates Practice Change in Breast Radiotherapy. Clin Oncol (R Coll Radiol). 2019 Jan;31(1):5-8. doi: 10.1016/j.clon.2018.08.007. Epub 2018 Sep 17. No abstract available.

Results Reference

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PubMed Identifier

17051947

Citation

Coles C, Yarnold J; IMPORT Trials Management Group. The IMPORT trials are launched (September 2006). Clin Oncol (R Coll Radiol). 2006 Oct;18(8):587-90. doi: 10.1016/j.clon.2006.07.010. No abstract available.

Results Reference

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Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery

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