BREAST CANCER PHASE 3
CLINICAL TRIALS
Breast Cancer Phase 3 Trials Recruiting for HR-positive/HER2-negative. Quick reference guide to trials that are likely to be currently recruiting in the the US.
Trial Name
Trial Type
What is being tested?
Why is this trial significant?
Who might qualify
Who is likely to be excluded?
CAPItello-292
New Approach
Whether the addition of capivasertib (inhibitor of AKT, part of a key cancer cell growth pathway) to standard first-line treatment is more effective.
It further investigates and targets the AKT pathway. This is a key mechanism of resistance to hormone treatment.
- HR-positive
- HER2-negative
- Locally advanced (inoperable) or metastatic cancer
- No prior treatment for advanced cancer
- Previous CDK4/6 inhibitor or fulvestrant
- Previous AKT or PI3K inhibitor.
Re-Discover-2
New Drug
RLY-2608, a newer, more selective inhibitor of a key growth signal pathway (PI3K-AKT-mTOR) versus capivasertib, an existing, broader acting AKT inhibitor.
It compares two “precision medicine” drugs head to head. Does more targeted action reduce side effects and/or increase treatment effects?
- HR-positive
- HER2-negative
- Locally advanced or metastatic cancer
- Recurrence or progression on prior treatment
- Confirmed PIK3CA mutation
(by biopsy or blood test).
- Negative for PIK3CA mutation
VIKTORIA-2
New Drug
Gedatolisib (an inhibitor of PI3K and mTOR) with a CDK4/6 inhibitor and hormone therapy versus standard first-line treatment.
Gedatolisib blocks multiple parts of the PI3K-AKT-mTOR signalling pathway so may further reduce tumor resistance.
- HR-positive HER2-negative
- Locally advanced or metastatic cancer
- Prior CDK4/6 inhibitor or PI3K-AKT-mTOR inhibitor
HERTHENA- Breast04
New Drug
Patritumab durextecan – an antibody-drug conjugate (ADC) versus current practice. ADCs deliver chemotherapy to specific target cells, in this case, those expressing HER3.
There is no agreed best practice once CDK4/6 treatment stops working, and older chemotherapy drugs are still widely used in this scenario.
- HR-positive
- HER2-negative
- Locally advanced or metastatic cancer
- Cancer progression after CDK4/6 inhibitor + hormone therapy
- Active or untreated interstitial lung disease
ELEGANT
New Approach
Elacestrant, a selective estrogen receptor degrader (SERD), versus existing hormone treatments (such as tamoxifen).
SERDs are part of the next generation of hormone treatments. Elacestrant is already used in advanced breast cancer but this trial investigates use at an earlier stage.
- HR-positive
- HER2-negative
- Early stage
- High chance of recurrence
- Completed >24m and <60m of hormone treatment
- >6m break in standard hormone treatment
CAMBRIA-1
New Drug
Whether switching to camizestrant, a new SERD, is advantageous compared to continuing standard hormone treatment.
Combined with other trials on SERDs, this will increase understanding of whether they can help overcome some of the resistance that breast cancer may develop to existing hormone treatments.
- HR-positive
- HER2-negative
- Early stage
- Intermediate or high chance of recurrence
- Completed >24m and <60m of hormone treatment
- Complete response to pre-surgical treatment
CAMBRIA-2
New Drug
Camizestrant, a new SERD, versus existing hormone treatments. It is used straight away after surgery.
This explores use of SERDs earlier in the treatment journey.
- HR-positive
- HER2-negative
- Early stage
- Intermediate or high chance of recurrence
- Not yet received post-surgical treatment
- Complete response to pre-surgical treatment
OFSET
New Approach
Whether chemotherapy is required if ovarian suppression and hormone treatment is given.
This is a de-escalation trial looking at whether chemotherapy can be removed from the treatment protocol for some women.
- HR-positive
- HER2-negative
- Pre-menopausal
- Early stage
- Oncotype Recurrence Score ≤25
- <16 weeks since surgery
- Any radiation therapy, chemotherapy, or biotherapy
- >6 weeks hormone treatment
S2206
New Approach
Whether the addition of durvalumab to neoadjuvant (before surgery) chemotherapy is beneficial.
This investigates the role of immunotherapy in addition to chemotherapy before surgery when the risk of recurrence is high, and whether the MammaPrint test is useful for identifying those who would benefit most.
- HR-positive
- HER2-negative
- Stage II or II
- MammaPrint Ultrahigh Risk / MP2 result
- Suitable for chemotherapy followed by surgery
- Any prior chemotherapy or similar treatment for this cancer
DEBRA
New Approach
Compares surgery followed by radiotherapy with hormone treatment to surgery followed by hormone treatment alone.
This is a de-escalation trial looking at whether radiotherapy is required after surgery for small, very early stage cancers.
- HR-positive
- HER2-negative
- Stage I
- Cancer completed removed by lumpectomy
- Oncotype Dx recurrence score <19
- Any lymph node radiation is required