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

Breast Cancer Clinical Trial

— IMPORT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00814567
• Other study ID #: CDR0000629768
• Secondary ID: NIHR 2253ICR-CTS
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2007
• Est. completion date: September 2020

Study information

• Verified date: February 2019
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2018
• Est. completion date: September 2020
• Est. primary completion date: June 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• radiation therapy
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment		5 years
Secondary	Location of tumor relapse		5 years
Secondary	Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment		5 years
Secondary	Regional and distant metastases		5 years
Secondary	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		5 years
Secondary	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		5 years
Secondary	Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years		10 years