Gut bacteria and their association with chemotherapy response in early breast cancer patients

Inclusion criteria:
1. Unequivocal evidence of metastatic disease.
2. History of active, uncontrolled gastrointestinal (GI) disorders, including:
2.1. Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe) and Crohn’s disease (mild-moderate-severe) or indeterminate colitis
2.2. Irritable bowel syndrome (IBS) (severe or on regular medication)
2.3. Persistent infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology or clostridium difficile infection (recurrent) 
3. Major gastrointestinal surgery with the exception of appendicectomy and cholecystectomy. Any bowel resection at any time. 
4. Treatment with systemic corticosteroids (intravenous or oral) or other immunosuppressive therapy for any other condition (including but not limited to prednisolone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumour necrosis factor [TNF] agents) within 28 days prior to Cycle 1 of neoadjuvant chemotherapy. The use of inhaled corticosteroids is allowed, as well as the use of mineralocorticoids (e.g. fludrocortisones) and low-dose supplemental corticosteroids for adrenocortical insufficiency and for orthostatic hypotension.
5. Confirmed or suspected state of immunodeficiency (primary or acquired) including HIV, hepatitis B and hepatitis C infection
6. Recent COVID-19 infection (≤ 28 days) or close contact with someone known to test positive (≤ 14 days).
7. Pregnant and/or breastfeeding individuals
8. Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the study

Exclusion criteria:
1. History of active, uncontrolled gastrointestinal (GI) disorders, including:
1.1. Inflammatory bowel disease (IBD) including ulcerative colitis  (mild-moderate-severe) and Crohn’s disease (mild-moderate-severe) or indeterminate colitis
1.2. Irritable bowel syndrome (IBS) (severe or on regular medication)
1.3. Persistent infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology, clostridium difficile infection (recurrent) or helicobacter pylori infection (untreated)
2. Major GI surgery with the exception of appendicectomy and cholecystectomy. Any bowel resection at any time.  
3. History of breast malignancy at any time or non-breast malignancy, requiring systemic therapy within the last 24 months.
4. Use of oral antibiotics within the last 6 weeks
5. Using a food exclusion diet due to diagnosis of food allergies or other food intolerances.
6. Individuals on medication requiring regular medical consultations (≤ 6 monthly)
7. Routine use of proprietary probiotics or prebiotics; in tablets, capsules or in powder form.
8. Recent COVID-19 infection (≤ 28 days) or close contact with someone known to test positive (≤ 14 days).
9. Pregnant and/or breastfeeding individuals
10. Other severe or uncontrolled systemic disease or evidence of any other significant disorder that makes it undesirable for the patient to participate

• UK access: residence, not citizenship

  Being a British citizen does not by itself entitle you to free NHS treatment; entitlement runs on being ordinarily resident in the UK.

  The UK and EU agreed to continue a planned-treatment scheme equivalent to S2 from 1 January 2021, so an S2 issued by an EU insurer is the thing to ask about for a UK trial. Put the question to both your insurer and the trial coordinator, since sponsors sometimes cover trial-related care regardless.

  Verify with: NHS: planned treatment abroad and the S2 route

  Ask both; not free by citizenship

• Free patient navigation

  myTomorrows (Amsterdam) provides medically trained, multilingual patient navigators who search ClinicalTrials.gov, EU CTIS and ISRCTN and can support a doctor through an expanded-access application. Free to patients and families.

  A navigator keeps searching after any single page stops being current. Use it alongside this site, not instead of your oncologist.

  Verify with: myTomorrows for patients

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