Triple Negative Breast Cancer (TNBC)Phase 2TNBCNCT03554109
QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine
A Phase 2 study testing Leucovorin, 5-Fluorouracil and Aldoxorubicin HCl in people with Triple Negative Breast Cancer (TNBC), run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Leucovorin, 5-Fluorouracil and Aldoxorubicin HCl
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2018to 9 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- Histologically confirmed stage II or III TNBC. Subjects must be treatment naïve. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and progesterone receptor (PgR) expression, and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Have at least 1 measurable lesion of ≥ 1.0 cm.
- Must have a recent FFPE tumor biopsy specimen and be willing to release the specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator.
Show all 9Show fewer
- Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.
Who cannot join
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, and autoimmune disease associated with lymphoma).
- History of organ transplant requiring immunosuppression.
- History of or active inflammatory bowel disease (eg, Crohn's disease and ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results:
- Absolute neutrophil count (ANC) < 1,000 cells/mm^3.
Show all 26Show fewer
- Platelet count < 75,000 cells/mm^3.
- Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).
- Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
- Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
- Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
- Serum creatinine > 2.0 mg/dL or 177 μmol/L.
- Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
- Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
- Serious myocardial dysfunction defined by echocardiogram (ECHO) as absolute LVEF 10% below the institution's lower limit of predicted normal.
- Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
- Positive results of screening test for human immunodeficiency virus (HIV).
- Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
- Known hypersensitivity to any component of the study medication(s).
- Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
- Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
- Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
- Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Concurrent participation in any interventional clinical trial.
- Pregnant and nursing women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
About this study
Official title: An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC
This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).
Read the detailed description
Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. The neoadjuvant phase will be 18 weeks for patients enrolled in the experimental arm and 16 weeks for those enrolled in the control arm.
Following the neoadjuvant phase, all subjects will undergo determination of their current response status and appropriate breast surgery and node dissection after which assessment for pCR will be conducted following completion of neoadjuvant systemic therapy. Pathologists interpreting surgical specimens for pCR assessment will be blinded to the treatment arm.
All subjects, regardless of whether or not they have achieved a pCR, will then enter the postoperative phase where they will receive adjuvant treatment. A small portion of the corresponding neoadjuvant therapy, either nab-paclitaxel or paclitaxel, will be administered as adjuvant treatment postoperatively. Adjuvant treatment will continue in the postoperative phase until the subject experiences unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- Leucovorin, 5-Fluorouracil, Aldoxorubicin HCl, nab-Paclitaxel, ETBX-011
- Keywords
- TNBC
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucovorinDrug
L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
5-FluorouracilDrug
5-fluoro-2,4 (1H,3H)-pyrimidinedione
Aldoxorubicin HClDrug
albumin-binding prodrug of doxorubicin HCl
nab-PaclitaxelDrug
Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
ETBX-011Biological
Ad5 [E1-, E2b-]-CEA
ETBX-051Biological
Ad5 [E1-, E2b-]-Brachyury vaccine
ETBX-061Biological
Ad5 [E1-, E2b-]-mucin 1[MUC1]
GI-4000Biological
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
GI-6207Biological
CEA yeast vaccine
GI-6301Biological
Brachyury yeast vaccine
AvelumabDrug
Avelumab
ALT-803Biological
Recombinant human super agonist interleukin-15 (IL-15) complex
haNKBiological
NK-92 [CD16.158V, ER IL-2]
CyclophosphamideDrug
2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Doxorubicin HCLDrug
Doxorubicin HCL
paclitaxelDrug
paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | NANT Neoadjuvant Triple Negative Breast Cancer Vaccine
A combination of agents will be administered to subjects in this study:
cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, avelumab, aldoxorubicin HCl, ALT-803, haNK, GI-4000, GI-6207, GI-6301, ETBX-011, ETBX-051 and ETBX-061 Receives: Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Aldoxorubicin HCl; Drug: nab-Paclitaxel; Biological: ETBX-011; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-4000; Biological: GI-6207; Biological: GI-6301; Drug: Avelumab; Biological: ALT-803; Biological: haNK; Drug: Cyclophosphamide |
| Group B | Active comparator | Standard treatment with a combination of doxorubicin, cyclophosphamide and paclitaxel. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin HCL; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response Rate
Compare the efficacy of the NANT neoadjuvant TNBC Vaccine treatment vs standard-of-care (SoC) therapy as assessed by pathologic complete response (pCR) rate in the breast and axilla.
Measured: 8 months
Secondary outcomes (5)
Evaluation of safety as determined by incidence or treatment-emergent adverse events
Incidence of treatment -emergent adverse events
Measured: 36 months
Evaluate additional measures of efficacy by event-free survival
Time from randomization to first occurrence of advancement of disease
Measured: 36 months
Overall survival
Time from date of first treatment to death from any cause
Measured: 36 months
Locoregional relapse
Presence of any disease recurrence, including location
Measured: 36 months
Distant metastatic rates at 1 year
Number of patients with a metastatic lesion
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startSep 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completion9 Feb 2022
Why it stopped: Trial not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. For the experimental arm, subjects will receive treatment in the neoadjuvant phase for six 3-week cycles (ie, 18 weeks total). For the control arm, subjects will receive neoadjuvant treatment for a total of 16 weeks.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554109
- Sponsor's protocol ID
- QUILT-3.057
- Acronym
- TNBC
- Status last verified
- Aug 2018
- First submitted
- 25 May 2018
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC
- ClinicalTrials.gov ID
- NCT03554109
- Acronym / sponsor ID
- TNBC / QUILT-3.057
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Keywords
- TNBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).
Detailed description
Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. The neoadjuvant phase will be 18 weeks for patients enrolled in the experimental arm and 16 weeks for those enrolled in the control arm.
Following the neoadjuvant phase, all subjects will undergo determination of their current response status and appropriate breast surgery and node dissection after which assessment for pCR will be conducted following completion of neoadjuvant systemic therapy. Pathologists interpreting surgical specimens for pCR assessment will be blinded to the treatment arm.
All subjects, regardless of whether or not they have achieved a pCR, will then enter the postoperative phase where they will receive adjuvant treatment. A small portion of the corresponding neoadjuvant therapy, either nab-paclitaxel or paclitaxel, will be administered as adjuvant treatment postoperatively. Adjuvant treatment will continue in the postoperative phase until the subject experiences unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. For the experimental arm, subjects will receive treatment in the neoadjuvant phase for six 3-week cycles (ie, 18 weeks total). For the control arm, subjects will receive neoadjuvant treatment for a total of 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Leucovorin, Drug: 5-Fluorouracil, Drug: Aldoxorubicin HCl, Drug: nab-Paclitaxel, Biological: ETBX-011, Biological: ETBX-051, Biological: ETBX-061, Biological: GI-4000, Biological: GI-6207, Biological: GI-6301, Drug: Avelumab, Biological: ALT-803, Biological: haNK, Drug: CyclophosphamideNANT Neoadjuvant Triple Negative Breast Cancer Vaccine A combination of agents will be administered to subjects in this study: cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, avelumab, aldoxorubicin HCl, ALT-803, haNK, GI-4000, GI-6207, GI-6301, ETBX-011, ETBX-051 and ETBX-061 |
| Group B | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin HCL, Drug: paclitaxelStandard treatment with a combination of doxorubicin, cyclophosphamide and paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- Histologically confirmed stage II or III TNBC. Subjects must be treatment naïve. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and progesterone receptor (PgR) expression, and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Have at least 1 measurable lesion of ≥ 1.0 cm.
Key exclusion criteria (26 listed)
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, and autoimmune disease associated with lymphoma).
- History of organ transplant requiring immunosuppression.
- History of or active inflammatory bowel disease (eg, Crohn's disease and ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeucovorinL-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt | Drug | Group A |
| 5-Fluorouracil5-fluoro-2,4 (1H,3H)-pyrimidinedione | Drug | Group A |
| Aldoxorubicin HClalbumin-binding prodrug of doxorubicin HCl | Drug | Group A |
| nab-PaclitaxelBenzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin | Drug | Group A |
| ETBX-011Ad5 [E1-, E2b-]-CEA | Biological | Group A |
| ETBX-051Ad5 [E1-, E2b-]-Brachyury vaccine | Biological | Group A |
| ETBX-061Ad5 [E1-, E2b-]-mucin 1[MUC1] | Biological | Group A |
| GI-4000Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins | Biological | Group A |
| GI-6207CEA yeast vaccine | Biological | Group A |
| GI-6301Brachyury yeast vaccine | Biological | Group A |
| AvelumabAvelumab | Drug | Group A |
| ALT-803Recombinant human super agonist interleukin-15 (IL-15) complex | Biological | Group A |
| haNKNK-92 [CD16.158V, ER IL-2] | Biological | Group A |
| Cyclophosphamide2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate | Drug | Group A, Group B |
| Doxorubicin HCLDoxorubicin HCL | Drug | Group B |
| paclitaxelpaclitaxel | Drug | Group B |
Primary outcome
Pathological Complete Response Rate
Time frame: 8 months
Compare the efficacy of the NANT neoadjuvant TNBC Vaccine treatment vs standard-of-care (SoC) therapy as assessed by pathologic complete response (pCR) rate in the breast and axilla.
5 secondary outcomes
Evaluation of safety as determined by incidence or treatment-emergent adverse events
Time frame: 36 months
Evaluate additional measures of efficacy by event-free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
Locoregional relapse
Time frame: 36 months
Distant metastatic rates at 1 year
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Triple Negative Breast Cancer (TNBC)
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leucovorin, 5-Fluorouracil and Aldoxorubicin HCl in people with Triple Negative Breast Cancer (TNBC), run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response Rate (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.