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Breast CancerIMPORTNCT00814567

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

A study testing radiation therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,018 participants
Where
1 siteUnited Kingdom
Study dates
3 May 2007to Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

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 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
radiation therapy
Keywords
recurrent breast cancer, stage IA breast cancer, stage II breast cancer, invasive ductal breast carcinoma, invasive ductal breast carcinoma with predominant intraductal component
Medical subject headings
Breast Neoplasms, Carcinoma, Ductal, Breast

What participants receive

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

  • radiation therapyRadiation

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

Study groups in NCT00814567
Study groupRoleWhat they receive
Arm I (control)Active comparatorPatients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.
Receives: Radiation: radiation therapy
Arm IIExperimentalPatients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
Receives: Radiation: radiation therapy
Arm IIIExperimentalPatients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
Receives: Radiation: radiation therapy

What is being measured

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

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

    Measured: 5 years

Secondary outcomes (6)

  1. Location of tumor relapse

    Measured: 5 years

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

    Measured: 5 years

  3. Regional and distant metastases

    Measured: 5 years

  4. 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

    Measured: 5 years

  5. 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

    Measured: 5 years

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

    Measured: 10 years

Timeline

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

  1. First posted25 Dec 2008 (estimated)
  2. Study start3 May 2007
  3. Primary completion15 Jun 2016
  4. Study completionSep 2020 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,018 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00814567
Sponsor's protocol ID
CDR0000629768
Other IDs
NIHR 2253, ICR-CTSU/2006/10001, ISRCTN12852634, CRUK/06/003, 06/Q1605/128
Acronym
IMPORT
Status last verified
Feb 2019
First submitted
24 Dec 2008
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28779963

  • 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.

    PubMed 30532984

  • 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.

    PubMed 30236641

  • 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.

    PubMed 17051947

Questions about this trial

What is this clinical trial studying?

A study testing radiation therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Results are not available in the source record.

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?

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). 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 NCT00814567, which also lists 4 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 27 Feb 2019.

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