Mammo-50 Eligibility Queries

Transcription

1 Mammo-50 Eligibility Queries Are patients who have received either neo-adjuvant or adjuvant chemo, radiotherapy or been part of another trial, ie OPTIMA, FAST FORWARD excluded from entry? Any patients are eligible provided they have had potentially curative treatment for early stage breast cancer and are disease free at three years. So therefore, any chemotherapy or radiotherapy is permitted, we will collect details on the baseline CRF. As far as Mammo-50 is concerned patients can have been in any other trial of neo-adjuvant or adjuvant treatment. It would depend on the follow-up schedule for the original trial, if they specify that patients must have annual mammography for longer than three years post-surgery then the patient would not be eligible for mammo-50. A patient was in the Poetic study 3 years ago and is now in follow up for 10 years. This patient meets all the eligibility criteria for Mammo-50 - are they able to go into Mammo-50 having been on Poetic? Yes that is fine as long as the follow up for the trial doesn t include a scheduled mammogram. After speaking with the Poetic trial team they confirmed that Poetic patients can take part in the Mammo-50 study. In the protocol it states that patients need to be 3 years post curative surgery, is it 3 years to the date or will patients be eligible if they had surgery in September and the 3 year mammogram appointment is July? The time frame for the three year mammogram is within months after surgery. In this instance if the three mammogram happens in the July before their three year surgery anniversary they would be eligible because they have received their mammogram in the 34 th month after their first therapeutic operation. This patient could not be randomised until the three year surgery anniversary date thought. However if the three year mammogram was happening in the July after the three year post surgery date this would mean the mammogram had been carried out in the patients 46 th month after their first therapeutic operation which would therefore make them ineligible. In a patients oncology notes it mentions that she had Mycosis fungoides of the right elbow. When looking at the MDT discussion regarding this they have said that this is not a cancer diagnosis, however I was under the impression that this was for lymphoma. She has received a course of course of narrow wave UVB and use Elocon ointment. She was diagnosed in 2006 and is reviewed annually with the dermatology consultants. Could confirm if this patient is eligible for Mammo-50? This patient should only enter the cohort not the main study. This is because Lymphoma is classed as a malignancy and it hasn t been 10 years since the patients diagnosis. Bowens Disease of the Breast Bowens Disease is a pre-cancerous skin lesion. On that basis the patient would be ineligible.

2 On the eligibility form for the question: No previous diagnosis of malignancy are the two sub points separate? 1-Managed by surgical treatment only and disease free for 10 years 2-Previous basal cell carcinoma of the skin or cervical intraepithelial neoplasia I m querying this because there is patient who had basal cell carcinoma 3 years ago, are they eligible? Yes the two points are separate because basal cell carcinoma is not classes as a malignancy and is benign therefore the patient is eligible to enter Mammo-50. Please can you advise on the following and if she is eligible; it s relating to the timing of mammograms. The patient had a Mx + recon etc in July Mammogram 1 took place on 20/7/12, mammogram 2 on 15/7/13, but had a third mammogram early this year in January due to pain. This is too early for the 3rd mammogram on the study. She isn't planned for another until Dec 14/Jan 15, which although inside the upper limit for entry, will technically be her 4th Mammogram. She is interested in the study, but I want to know if you would be happy with the above. Do I count the one down early as her third mammogram (but if this is the case, not eligible) Technically the one in January is her third mammogram since surgery, but was done as an investigation into symptoms so, please class the mammogram booked for Dec14/Jan15 as the patients 3 year mammogram. This will mean the patient is eligible to ether the trial. We have a patients who had breast cancer surgery in 1997 for her original cancer (she also had 5 years of Tamoxifen) and then surgery for local recurrence 3 years ago. Would the previous breast cancer deem her ineligible? Unfortunately this patient isn t eligible for Mammo-50. There are two reasons: The patient received Tamoxifen for their original cancer not just surgery The original cancer was breast cancer. Lady with a Basal Cell Carcinoma however when looked at more closely there was a mix of Basal and Squamous cells found. But diagnosis of Balsa Cell Carcinoma given This is a skin malignancy and would be outside our eligibility criteria. Squamous skin cancer or Melanoma would be excluded and therefore make the patient ineligible. Could I just check that a patient diagnosed with episodes of seborrhoeic keratosis and G1 benign neoplasm of the skin is still eligible? Because they have a benign skin or non-invasive epithelial tumour then they should be eligible. I have a patient who is interested in the Mammo 50 trial. Her surgery date was 25 Jan 2011 and her last mammogram 2 April Can she be included in the study or is she too far from her surgery date? I m sorry but the patient is too close to their four surgery date. As you are aware the latest a three year mammogram can be carried out is 8 months after the patients three year surgery date (44 months from first therapeutic operation) this is what we are also classing as our cut off for randomising/registering patients.

3 We have a potential patient who is interested in joining the trial. However we are not entirely sure if she is eligible for the trial due to the scheduling of her mammograms. Here is a short history of the patient: Had WLE on 18/Nov/2010 and a completion mastectomy in 6/Jan/2011. Patient also had Mammograms on 10/5/2012, 7/5/2013 & 6/1/2014. Because of the mammogram in 2014, we are unsure if this would be regarded as a 4 th year mammogram or because it is before November if it would be considered an intermediary mammogram. Yes this patient is eligible. Their three year mammogram date was 06/01/2014 this means the mammogram happened 38 months after their first therapeutic operation date, 18/11/2010. The eligibility criteria states that the three year mammogram needs to have been carried out between 32 and 44 months after their 1st therapeutic operation. The patient can be randomised anytime up to their four year surgery anniversary which is 18/11/2014. Before randomising this patient please can you make sure they are aware that because they had a mastectomy they may be assigned to three yearly mammograms and this could mean the patient may not be due another mammogram until Jan 2017 (three years since their last) If the patient isn t comfortable with this idea please remember that we have the Cohort Study that she could enter. I m finding quite a few ladies between 75 and 80 who would be eligible for MAMMO 50. What happens to these patients as regards to the Breast Screening Programme? We are not taking any patients out of the breast screening programme whilst they are on Mammo- 50. They will continue to receive appointments and we are just asking that they only attend for Mammo-50 mammograms during their time on the trial. Once they have finished trial treatment they should attend for screening appointments as previously. Regarding this age group I have looked on the NHSBSP website and currently only women up to the age of 70 are invited for screening although it appears there are plans to extend this to 73 by It is my understanding that this age group of women will no longer be in the breast screening programme when they are entered into the trial. Once their trial treatment has finished their frequency of mammographic follow up will be the same as for other non-trial patients in this age group and according to your own local policy. I am currently screening a lady who has had her yr3 mammo within the correct timeframe for trial entry, but for an unknown reason this lady never had a yr 2 mammo, does this make her ineligible for the trial? This patient is still eligible so long as she has had a clear three year mammogram. I am screening a lady who appears to meet all of the timeline eligibility criteria but I m not sure about her histology. This lady was diagnosed with lobular neoplasia in situ (LCIS) which has been treated the same as DCIS. Is this eligible for MAMMO-50? This patient is not eligible due to there being no evidence of a DCIS or Invasive cancer

4 I am screening a lady who had pre-op letrozole for 5 months before having her curative surgery. I think was due to having had an M.I and the drs wanted to wait 6 months post M.I before having anaesthetic. Would this affect her eligibility for MAMMO-50? I can confirm that from the information you have given this lady is eligible, we are happy for patients who have had pre-op chemotherapy or hormone treatment to enter the study. I have a patient who is eligible for Mammo 50 in all way except that, her year 3 mammo was on , and the month window following surgery was , would this make her ineligible? If the lady we spoke about had her first therapeutic operation on 06/12/2011 and her three year mammogram on 03/10/2014 this would mean the lady had her three year mammogram at around 34 months post first therapeutic operation. Which means she fits perfectly into the month window we allow for the three year mammogram to take place. Also because the ladies three year surgery anniversary date was 06/12/2014 this means she is now 37 months post her first therapeutic operation. Which means she also fits into perfectly into the month window we allow for randomisation to take place. Is a lady who has had Paget s disease eligible? The lady is following the same treatment pathway as though she has had a DCIS. Co-Chief Investigators have requested that when we have patient with Paget's disease alone the pathology report is reviewed by the Mammo-50 Co Chief Investigators. Please contact the trial office on for more information. A lady had 36mm of DCIS and when she had a WLE there were three areas of invasive cancer found within the DCIS. When the histopathology report came back one of the invasive parts was at the medial margin. The lady had radiotherapy after the WLE. The reason I m querying this ladies eligibility is because one of the inclusion criteria is: Excised invasive breast cancer with local treatment completed Does the fact that invasive cancer was found at the medial margin class as excised invasive breast cancer? I think it is down to how close the medial margin was.the National Guidance is margin should be equal to or greater than 1 mm circumferentially (ie medially). If the margin was involved or less than 1mm I think she would be ineligible as she would have a greater risk of local recurrence. Sometimes the surgeon may qualify the report on BCCOM to say the medial margin is also the anterior or skin, in which case it as acceptable and the patient gets a radiation boost.

5 I have just spoken to the patient who is very keen on the trial however she has told me that she had a breast primary 30 years ago treated with mastectomy and radiotherapy. Her DCIS was an incidental finding when she had reconstruction to her left breast and a reduction of her right in The tissue from the reduction was sent to histopathology and DCIS was found - all had been removed and she did not require any further surgery/treatment. Unfortunately this patient isn t eligible due to: The patient has had a previous breast primary. Bilateral disease (cancer removed 30 years ago was left breast incidental DCIS right breast) Treated for another malignancy with not just surgery alone (the breast cancer the lady had 30 years ago was treated with surgery and radiotherapy) We have an eligible patient for the trial who has previously been in another trial titled Supremo (Radiotherapy vs No radiotherapy) The Supremo trials team are happy for the patient to take part in the Mammo-50 trial but I wanted to check you would be happy with this? So long as the follow-up for Supremo doesn t stipulate that the lady has to have a certain mammogram schedule then she ll be eligible. A potential patient had a left mastectomy in 1994 for breast cancer, they had no radiotherapy or chemotherapy but did have Tamoxifen for 5 years. In 2012 they had a right WLE and node biopsy following a screen detected breast cancer, they had radiotherapy and is on Tamoxifen. Unfortunately this lady isn t eligible, the reasons are: This lady has had a previous breast cancer The ladies breast cancer is bilateral (left Mastectomy and right WLE) Are patients with bilateral implants eligible? We accept patients with bilateral implants, however we don t accept patents with bilateral cancer. If they lady has bilateral implants for cosmetic reasons this is fine however if she has the implants due to bilateral cancer she will not be eligible. If a patient has had Cancer in Axillary tail only are they eleigible? Unfortunately the patient we spoke about on the phone isn t eligible this is due to her not having clear evidence of a defined primary invasive breast cancer even though it has been treated this way. Also at randomisation the patients are stratified on whether they have had a WLE or mastectomy in this ladies case she s had neither so our randomisation system wouldn t be able to allocate her an arm. Patient has pleomorphic LCIS - is she eligible Pleomorphic LCIS behaves and is treated as high grade DCIS so she should be included. Classical LCIS alone is a risk factor only and should not be included.