No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
University Hospital Heidelberg · Other
Who this trial is looking for
This trial is looking for women with a recent recurrence of breast cancer who have had previous radiation treatment. Participants will receive proton beam therapy to the breast over several sessions to see how it affects skin reactions.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with recurrent invasive breast cancer or DCIS.
I have had breast-conserving surgery recently.
My tumor is less than 3 cm.
I have no cancer spread to my lymph nodes.
My surgical margins are clear of cancer.
It has been at least 12 months since my last radiation treatment.
I can understand the trial and its consequences.
I am at least 18 years old.
You may not be able to join if
I have distant metastases.
I am currently receiving chemotherapy.
I have not recovered from the side effects of previous treatments.
I was diagnosed with cancer within the last 5 years that needs immediate treatment.
I am pregnant or breastfeeding.
I am participating in another competing clinical study.
I have a history of active connective tissue disorder.
I have medical implants not eligible for the treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Breast cancer is the most common malignancy in women. Breast-conserving surgery (BCS) with adjuvant whole-breast irradiation (WBI) is currently the standard of care in the oncological treatment of primary breast cancer and offers an equivalent alternative to mastectomy. The primary aim of adjuvant radiotherapy (RT) is to improve local control and thus improve overall survival and breast cancer-spe…
Breast cancer is the most common malignancy in women. Breast-conserving surgery (BCS) with adjuvant whole-breast irradiation (WBI) is currently the standard of care in the oncological treatment of primary breast cancer and offers an equivalent alternative to mastectomy. The primary aim of adjuvant radiotherapy (RT) is to improve local control and thus improve overall survival and breast cancer-specific mortality. However, nodal-negative women have a 10-year risk for local recurrences after RT in up to 15.6%. The management of ipsilateral breast cancer recurrence depends on the extent of tumor disease and staging results at the time of recurrence and mastectomy is currently the standard of care for previously irradiated patients. The application of particle therapy using proton beam therapy (PBT) represents an innovative radiotherapeutic technique for breast cancer patients. This trial will be conducted as a prospective single-arm phase II study in 20 patients with histologically proven invasive breast cancer recurrences with negative margins after repeat BCS and with an indication for local re-irradiation. Required time interval will be 1 year after previous RT to the ipsilateral breast. Patients will receive partial breast re-RT with proton beam therapy in 15 once daily fractions up to a total dose of 40.05 GyRBE. The primary endpoint is defined as the cumulative overall occurrence of acute / subacute skin toxicity grade ≥3 within 6 months after the start of re-RT.
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Eligibility Criteria
Inclusion Criteria:
* histologically confirmed recurrent (or new primary) ipsilateral invasive breast cancer or DCIS after prior RT of the ipsilateral breast
* indication for re-irradiation after repeat breast conserving surgery (e.g. lumpectomy, wide excision, …)
* tumor size \< 3 cm
* clinically …
Inclusion Criteria:
* histologically confirmed recurrent (or new primary) ipsilateral invasive breast cancer or DCIS after prior RT of the ipsilateral breast
* indication for re-irradiation after repeat breast conserving surgery (e.g. lumpectomy, wide excision, …)
* tumor size \< 3 cm
* clinically node-negative (cN0)
* negative resection margin (R0)
* time interval: start of re-RT to prior RT ≥ 12 months
* ECOG Performance status ≤ 2
* ability of subject to understand character and individual consequences of the clinical trial
* written informed consent
* ≥18 years of age
Exclusion Criteria:
* distant metastases
* concomitant chemotherapy (concomitant endocrine hormonal therapy is allowed; sequential chemotherapy is allowed)
* patients who have not recovered from acute toxicities of prior therapies
* known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
* pregnant or lactating women
* participation in another competing clinical study or observation period of competing trials
* history of active connective tissue disorder (i.e. systemic lupus erythematosus, scleroderma, dermatomyositis, xeroderma pigmentosum, …)
* medical implants, which are at the time of reirradiation not eligible for particle therapy at Heidelberg Ion Beam Therapy Center
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