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CompletedLast updated: 12 February 2024

PIONEER: This trial is trying to determine the best way of delivering radiation therapy to the breast tissue of people diagnosed with invasive, Grade 1, 2 or 3 breast cancer, before surgeryA Pilot Study of Prone Position Neoadjuvant Breast Radiotherapy to Reduce Skin Toxicity

Clinical summary

Summary

The duration of this trial is expected to be 3 months for each participant. Radiotherapy treatment will commence at least 4-weeks after completion of standard chemotherapy and will be delivered 5-days a week, over 5-weeks. Approximately 4-8 weeks following successful completion of radiotherapy, the participant will have a surgery to remove the breast and immediate breast reconstruction.

Conditions

This trial is treating patients with breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

Not applicable

Trial Acronym

PIONEER

More information

Trial Identifiers

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Trial sponsor

Victorian Comprehensive Cancer Centre & Peter MacCallum Cancer Centre

Scientific Title

A Pilot Study of Prone Position Neoadjuvant Breast Radiotherapy to Reduce Skin Toxicity

Eligibility

Inclusion

Patient has provided written informed consent for the trial
Female patients greater than or equal 18 years of age on day of signing informed consent
Patient has histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma
Primary tumour is T2, T3 or T4 and N1+
Patient is a candidate for radiotherapy in the prone position and mastectomy with immediate autologous reconstruction as assessed by the breast surgeon, the plastic surgeon and the radiation oncologist
Patient has received neoadjuvant systemic therapy, including chemotherapy and/or targeted therapies
Patient ECOG Performance status of 0 or 1
Patient is willing and able to comply with the protocol requirements for the duration of the study including undergoing radiotherapy, surgery, scheduled visits and follow up

Exclusion

Inflammatory breast cancers with documented skin involvement
Presence of ductal carcinoma in situ (DCIS) alone
Pregnant or lactating patients
Contraindication to radiotherapy e.g. scleroderma
Prior radiotherapy which precludes giving radiotherapy with curative intent to breast and locoregional nodes

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.