Table 2.
Current active clinical trials for ctDNA in early-stage breast cancer *.
| Title of Study | Condition | Study Objective | Study Type/Design | Estimated Enrollment |
|---|---|---|---|---|
| HARMONY (NCT05433753) |
HER2+ receiving neoadjuvant therapy |
MRD detection using ctDNA to predict recurrence | observational, prospective |
60 |
| NCT04353557 | stage I–III | assess the prognostic and predictive value of ctDNA | observational, prospective |
200 |
| NCT05649475 | stage I–III undergoing NAT | whether ctDNA is a marker of response to NAT | observational, prospective |
100 |
| SURVIVE (NCT05658172) |
medium- and high-risk patients after completion of primary anti-tumor therapy | evaluate the potential benefits of intensified versus standard surveillance | partially double-blinded, interventional, randomized, controlled, superiority study | 3500 |
| CIPHER (NCT05333874) |
stage II–III TNBC and HER2+ | examine the impact of ctDNA on treatment decision-making in patients after NAT and surgery | interventional, non-randomized |
34 ** |
| TRAK-ER (NCT04985266) |
ER+ | demonstrate that palbociclib and fulvestrant can defer or prevent relapse in patients with ctDNA-detected molecular relapse | interventional, randomized, phase II study |
1100 |
| DARE (NCT04567420) |
stage II–III HR+/HER2− |
assess the incidence of ctDNA detection in patients who receive standard-of-care endocrine AT and have high risk of recurrence and assess whether palbociclib plus fulvestrant improves relapse-free survival in ctDNA+ patients | interventional, randomized |
100 |
| LEADER (NCT03285412) |
ER+ | ctDNA for MRD detection and therapy guidance | interventional, randomized |
120 |
| NCT04768426 | TNBC | evaluate the use ctDNA to identify patients who will or will not benefit from treatment with capecitabine | interventional, phase II study |
25 |
| NCT03881384 | not specified | whether ctDNA detection can reflect the tumor response to NCT and detect MRD after surgery | observational, prospective |
200 |
| STRIVE (NCT03085888) |
women undergoing mammography screening | validate the ability of the GRAIL Test to detect early-stage breast and other invasive cancers | observational, prospective |
99,481 ** |
| RENOVATE (NCT04781062) |
women with radiologically identified lesions, BIRADS-3/4/5, smaller than 2 cm | develop a Horizontal Data Integration classifier enabling early noninvasive diagnosis | interventional, non-randomized |
367 ** |
| APOLLO (NCT04501523) |
stage II-III TNBC | use ctDNA to identify patients with high relapse risk and randomize them to receive boost or standard therapy | interventional randomized, phase II | 460 |
| ARTEMIS (NCT04803539) |
stage II-III TNBC | identify high-risk patients and initiate boost therapy | interventional randomized, phase II/III | 120 |
* The terms “early breast cancer” or “stage I-III breast cancer” and “ctDNA” were used at clinicaltrials.gov and studies with the status “recruiting” and “active, not recruiting” are shown (1 May 2023). Manual inspection was performed to exclude inappropriate Studies. (** actual enrollment).