Breast CancerPhase 2NCT00616967
Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer
A Phase 2 study testing carboplatin, paclitaxel albumin-stabilized nanoparticle formulation and vorinostat in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- carboplatin, paclitaxel albumin-stabilized nanoparticle formulation and vorinostat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2008to Feb 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating ductal breast cancer by core needle biopsy
- Mixed ductal and lobular disease allowed
- Infiltrating lobular cancer allowed in the run-in portion only
- Unresected, clinically measurable disease, meeting 1 of the following clinical staging criteria:
- T2, T3, or T4 lesion, any N, M0
- T1c, N1-3,M0
- Patients with skin metastases to the ipsilateral breast for whom chemotherapy is planned prior to definitive surgery are eligible for the primary study portion
- HER2-negative disease
- Hormone receptor status* meeting 1 of the following criteria:
- Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative
- ER-positive (grade II or III) and PR-positive or PR-negative NOTE: *Any ER or PR status for the run-in portion
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Menopausal status not specified
- ANC ≥ 1,500/mm³
- Platelet count ≥ 150,000/mm³
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times the upper limit of normal (ULN)
- Creatinine clearance ≥ 50 mL/min
- Total bilirubin normal
- AST(SGOT) and ALT(SGPT) ≤ 2.5 times (ULN)
- alkaline phosphatase ≤ 2.5 times ULN
- PT such that INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and PTT ≤ ULN
- Adequate cardiac function defined as no evidence of PR prolongation or AV block on baseline electrocardiogram (ECG)
- Willing to use effective, non-hormonal contraception while on treatment and for at least 3 months thereafter
- Not pregnant or nursing
- No pre-existing peripheral neuropathy ≥ grade 2
- No history of severe hypersensitivity reaction to any drug formulated with polysorbate 80 or to E. coli-derived products
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
- No medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on this therapy
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior valproic acid or other histone deacetylase inhibitor
- No prior chemotherapy, radiotherapy, or endocrine therapy for this cancer
- Prior tamoxifen or raloxifene or another agent for prevention of breast cancer allowed as long as the patient has discontinued the treatment ≥ 1 month prior to baseline study biopsy
- No systemic treatment for prior cancer within the past 5 years (primary study portion)
- No prior or ongoing systemic treatment for this cancer (primary study portion)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent histone deacetylase inhibitor
- No other concurrent chemotherapy, antiestrogen therapy, radiotherapy, or other investigational systemic therapy
- No other concurrent biologic therapy
- No other concurrent investigational drugs
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anne Arundel Health System
Annapolis, Maryland, 21401
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35249
Indiana University Purdue University of Indianapolis
Indianapolis, Indiana, 46202
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: A Multi-Institutional Double-Blind Phase II Study Evaluating Response and Surrogate Biomarkers to Carboplatin and Nab-Paclitaxel (CP) With or Without Vorinostat as Preoperative Chemotherapy in HER2-negative Primary Operable Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To determine pathological complete response (pCR) rates in patients with HER2-negative primary operable breast cancer treated with neoadjuvant therapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (CP) with vs without vorinostat.
Secondary
- To evaluate the safety of these regimens in these patients.
- To estimate clinical complete response (cCR) rates in patients treated with these regimens.
- To correlate baseline and change (day 15) in surrogate uptake values (SUV) on FDG-PET with pathological and clinical response in patients treated with these regimens, and to determine what percent of women with ≥ 25% or ≥ 50% reduction in SUV on day 15 achieve a pCR and a cCR to CP with vs without vorinostat.
- To correlate baseline and change in markers of proliferation with pathological and clinical response in patients treated with these regimens.
- To evaluate long term outcomes (e.g., recurrence of the breast cancer, development of a new cancer, or death) for patients treated with these regimens.
Tertiary
- To evaluate baseline and change in candidate gene methylation and expression profiles.
- To evaluate baseline and change in tissue and peripheral blood mononuclear cell histone acetylation.
- To compare cCR and pCR in women with basal-like features versus other subtypes.
OUTLINE: This is a multicenter, randomized, double-blind, phase II study (primary study portion) with a 6-12 patient run-in portion.
- Run-in portion: Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Once safety of the combination of chemotherapy and vorinostat is confirmed, subsequently enrolled patients are entered to the primary study portion.
- Primary study portion: Patients are stratified by hormone receptor status (estrogen receptor [ER]-negative and progesterone receptor [PR]-negative vs ER-positive and/or PR-positive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
Within 2-4 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conserving surgery or mastectomy at the discretion of the treating physician.
Patients undergo tumor tissue biopsy at baseline, day 15, and at the time of definitive surgery. Samples are analyzed by immunohistochemistry (IHC), RNA extraction, and gene expression analysis using RT-PCR to identify candidate markers for response and molecular profiles that may be relevant to an understanding of drug mechanisms. Methylation of relevant genes (e.g., ERalpha, APC-1, RARbeta, cyclin D2, Twist, RASSF1A, and HIN-1) are evaluated by quantitative multiplex methylation-specific PCR. Changes in gene expression as a result of treatment are determined by IHC or quantitative RT-PCR. Blood samples are collected at baseline, day 15, at the time of definitive surgery, and 4 weeks after surgery for DNA methylation studies, pharmacogenomic studies, and histone acetylation assays. Patients also undergo fludeoxyglucose F 18-positron emission tomography (FDG-PET) or PET/CT at baseline and day 15 to assess treatment response as measured by standardized uptake values.
After completion of study treatment, patients are followed every 6 months.
- Conditions
- Breast Cancer
- Being tested
- carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, vorinostat, placebo
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, ductal breast carcinoma, lobular breast carcinoma
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called Paraplatin
Given IV
paclitaxel albumin-stabilized nanoparticle formulationDrug
Also called Abraxane, nab-Paclitaxel
Given IV
vorinostatDrug
Also called Zolinza
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: carboplatin; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: placebo |
| Arm II | Experimental | Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: carboplatin; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.
Measured: Time of breast cancer surgery
Secondary outcomes (10)
Safety as Measured by Number of Participants Who Experience Adverse Events
Number of participants who experience adverse events as defined by NCI CTCAE version 3.0
Measured: up to 30 days post-treatment
Number of Participants With Clinical Complete Response (cCR)
cCR in the breast on physical is defined as the absence of any palpable abnormality on breast exam Iie: no skin or breast thickening, mass or associated skin or nipple changes)
Measured: 12 weeks
Change in Standard Uptake Value (SULmax) From Baseline to Day 15 on FDG-PET
Change in standard uptake value (SULmax) as measured by percentage reduction of SULmax. The standard uptake value used for the PET analysis was SULmax, which is the standard uptake value normalized for lean body mass.
Measured: Baseline and day 15
Absolute Change From Baseline in Ki-67
Measured: Change from baseline to Cycle 1-Day 15
Change in Cumulative Methylation Index (CMI)
Change of CMI from baseline to Day 15 (D15), defined as log(D15 CMI + 1/baseline CMI + 1). The CMI was calculated as a sum of all gene-specific methylation indexes within a panel of 10 genes which included: HIST1H3C, AKR1B1, GPX7, HOXB4, TMEFF2, RASGRF2, COL6A2, ARHGEF7, TM6SF1, and RASSF1A.
Measured: Change from baseline to Day 15
Cumulative Methylation Index (CMI) at Day 15
Measured: Day 15
Number of Participants Who Experience Death During Treatment
Measured: Up to 12 weeks
Number of Participants Who Develop New Cancer
Measured: Up to death of last participant (duration unknown)
Number of Participants With Recurrence of Breast Cancer
Measured: Up to death of last participant (duration unknown)
Overall Survival
Measured: Up to death of last participant (duration unknown)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2014
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vered Stearns, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616967
- Sponsor's protocol ID
- J0785
- Other IDs
- P30CA006973, NA_00012756, JHOC-SKCCC-J0785, JHOC-J0785, CDR0000586335
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2008
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Connolly RM, Leal JP, Goetz MP, Zhang Z, Zhou XC, Jacobs LK, Mhlanga J, O JH, Carpenter J, Storniolo AM, Watkins S, Fetting JH, Miller RS, Sideras K, Jeter SC, Walsh B, Powers P, Zorzi J, Boughey JC, Davidson NE, Carey LA, Wolff AC, Khouri N, Gabrielson E, Wahl RL, Stearns V. TBCRC 008: early change in 18F-FDG uptake on PET predicts response to preoperative systemic therapy in human epidermal growth factor receptor 2-negative primary operable breast cancer. J Nucl Med. 2015 Jan;56(1):31-7. doi: 10.2967/jnumed.114.144741. Epub 2014 Dec 4.
PubMed 25476537Connolly RM, Fackler MJ, Zhang Z, Zhou XC, Goetz MP, Boughey JC, Walsh B, Carpenter JT, Storniolo AM, Watkins SP, Gabrielson EW, Stearns V, Sukumar S. Tumor and serum DNA methylation in women receiving preoperative chemotherapy with or without vorinostat in TBCRC008. Breast Cancer Res Treat. 2018 Jan;167(1):107-116. doi: 10.1007/s10549-017-4503-2. Epub 2017 Sep 16.
PubMed 28918548
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Institutional Double-Blind Phase II Study Evaluating Response and Surrogate Biomarkers to Carboplatin and Nab-Paclitaxel (CP) With or Without Vorinostat as Preoperative Chemotherapy in HER2-negative Primary Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00616967
- Acronym / sponsor ID
- J0785
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, ductal breast carcinoma, lobular breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 16 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To determine pathological complete response (pCR) rates in patients with HER2-negative primary operable breast cancer treated with neoadjuvant therapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (CP) with vs without vorinostat.
Secondary
- To evaluate the safety of these regimens in these patients.
- To estimate clinical complete response (cCR) rates in patients treated with these regimens.
- To correlate baseline and change (day 15) in surrogate uptake values (SUV) on FDG-PET with pathological and clinical response in patients treated with these regimens, and to determine what percent of women with ≥ 25% or ≥ 50% reduction in SUV on day 15 achieve a pCR and a cCR to CP with vs without vorinostat.
- To correlate baseline and change in markers of proliferation with pathological and clinical response in patients treated with these regimens.
- To evaluate long term outcomes (e.g., recurrence of the breast cancer, development of a new cancer, or death) for patients treated with these regimens.
Tertiary
- To evaluate baseline and change in candidate gene methylation and expression profiles.
- To evaluate baseline and change in tissue and peripheral blood mononuclear cell histone acetylation.
- To compare cCR and pCR in women with basal-like features versus other subtypes.
OUTLINE: This is a multicenter, randomized, double-blind, phase II study (primary study portion) with a 6-12 patient run-in portion.
- Run-in portion: Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Once safety of the combination of chemotherapy and vorinostat is confirmed, subsequently enrolled patients are entered to the primary study portion.
- Primary study portion: Patients are stratified by hormone receptor status (estrogen receptor [ER]-negative and progesterone receptor [PR]-negative vs ER-positive and/or PR-positive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
Within 2-4 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conserving surgery or mastectomy at the discretion of the treating physician.
Patients undergo tumor tissue biopsy at baseline, day 15, and at the time of definitive surgery. Samples are analyzed by immunohistochemistry (IHC), RNA extraction, and gene expression analysis using RT-PCR to identify candidate markers for response and molecular profiles that may be relevant to an understanding of drug mechanisms. Methylation of relevant genes (e.g., ERalpha, APC-1, RARbeta, cyclin D2, Twist, RASSF1A, and HIN-1) are evaluated by quantitative multiplex methylation-specific PCR. Changes in gene expression as a result of treatment are determined by IHC or quantitative RT-PCR. Blood samples are collected at baseline, day 15, at the time of definitive surgery, and 4 weeks after surgery for DNA methylation studies, pharmacogenomic studies, and histone acetylation assays. Patients also undergo fludeoxyglucose F 18-positron emission tomography (FDG-PET) or PET/CT at baseline and day 15 to assess treatment response as measured by standardized uptake values.
After completion of study treatment, patients are followed every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: carboplatin, Drug: paclitaxel albumin-stabilized nanoparticle formulation, Other: placeboPatients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: carboplatin, Drug: paclitaxel albumin-stabilized nanoparticle formulation, Drug: vorinostatPatients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatinAlso: ParaplatinGiven IV | Drug | Arm I, Arm II |
| paclitaxel albumin-stabilized nanoparticle formulationAlso: Abraxane, nab-PaclitaxelGiven IV | Drug | Arm I, Arm II |
| vorinostatAlso: ZolinzaGiven orally | Drug | Arm II |
| placeboGiven orally | Other | Arm I |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: Time of breast cancer surgery
The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.
10 secondary outcomes
Safety as Measured by Number of Participants Who Experience Adverse Events
Time frame: up to 30 days post-treatment
Number of Participants With Clinical Complete Response (cCR)
Time frame: 12 weeks
Change in Standard Uptake Value (SULmax) From Baseline to Day 15 on FDG-PET
Time frame: Baseline and day 15
Absolute Change From Baseline in Ki-67
Time frame: Change from baseline to Cycle 1-Day 15
Change in Cumulative Methylation Index (CMI)
Time frame: Change from baseline to Day 15
Cumulative Methylation Index (CMI) at Day 15
Time frame: Day 15
Number of Participants Who Experience Death During Treatment
Time frame: Up to 12 weeks
Number of Participants Who Develop New Cancer
Time frame: Up to death of last participant (duration unknown)
Number of Participants With Recurrence of Breast Cancer
Time frame: Up to death of last participant (duration unknown)
Overall Survival
Time frame: Up to death of last participant (duration unknown)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25476537Connolly RM, Leal JP, Goetz MP, Zhang Z, Zhou XC, Jacobs LK, Mhlanga J, O JH, Carpenter J, Storniolo AM, Watkins S, Fetting JH, Miller RS, Sideras K, Jeter SC, Walsh B, Powers P, Zorzi J, Boughey JC, Davidson NE, Carey LA, Wolff AC, Khouri N, Gabrielson E, Wahl RL, Stearns V. TBCRC 008: early change in 18F-FDG uptake on PET predicts response to preoperative systemic therapy in human epidermal growth factor receptor 2-negative primary operable breast cancer. J Nucl Med. 2015 Jan;56(1):31-7. doi: 10.2967/jnumed.114.144741. Epub 2014 Dec 4.
- Results publication: PubMed 28918548Connolly RM, Fackler MJ, Zhang Z, Zhou XC, Goetz MP, Boughey JC, Walsh B, Carpenter JT, Storniolo AM, Watkins SP, Gabrielson EW, Stearns V, Sukumar S. Tumor and serum DNA methylation in women receiving preoperative chemotherapy with or without vorinostat in TBCRC008. Breast Cancer Res Treat. 2018 Jan;167(1):107-116. doi: 10.1007/s10549-017-4503-2. Epub 2017 Sep 16.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
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 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Vered Stearns, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, paclitaxel albumin-stabilized nanoparticle formulation and vorinostat in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 5 sites 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?
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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 16 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (pCR) Rate (time frame: Time of breast cancer surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00616967, which also lists 2 linked publications.
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 5 Mar 2026.