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AzTrials

Breast CancerPhase 3NCT01354522

TAC Versus TCX as Adjuvant Treatment for High-risk Her2-Negative Breast Cancer

A Phase 3 study testing Docetaxel, Doxorubicin, Cyclophosphamide and Docetaxel, Cyclophosphamide, Capecitabine in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative breast cancer, while capecitabine is more effective in this group of patients. This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel, Doxorubicin, Cyclophosphamide and Docetaxel, Cyclophosphamide, Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteChina
Study dates
May 2011to Dec 2023
Phase
Phase 3
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.
  • Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
  • Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected.
  • Node-negative high-risk breast cancer was defined as tumors with a size ≥ 2 cm, fulfilling at least one of the following criteria: histological grade 3, estrogen receptor (ER)-negative and progesterone receptor (PR)-negative, or a Ki67 proliferation index ≥ 14%.
  • Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.
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  • Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with ICH 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.
  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 70.
  • Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
  • Laboratory results (within 14 days prior to randomization):
  • Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;
  • Hepatic function: total bilirubin <= 1 upper normal limit (UNL); SGOT and SGPT <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;
  • Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;
  • Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 prior days to randomization.

Who cannot join

  • Prior systemic therapy for breast cancer.
  • Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
  • Any T4 or M1 tumour.
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  • HER2 positive breast cancer (IHC 3+ or positive FISH result).
  • Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCI CTC v-2.0]).
  • Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled HA or high risk arrhythmias.
  • History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer; unstable diabetes mellitus.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Chronic treatment with corticosteroids.
  • Contraindications for corticosteroid administration.
  • Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.
  • Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
  • Concomitant treatment with another therapy for cancer.
  • Males.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Randomized, Phase III Study Comparing TAC (Docetaxel, Doxorubicin, Cyclophosphamide) With TCX ( Docetaxel, Cyclophosphamide, Capecitabine) as Adjuvant Treatment for High-risk Her2-Negative Breast Cancer

Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative breast cancer, while capecitabine is more effective in this group of patients.

This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive or node-negative high-risk breast cancer patients.

Read more

Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period.

Women with hormone receptor positive tumours must receive 5 years endocrine after the end of chemotherapy.

Patients may receive radiotherapy when clinically indicated.

Conditions
Breast Cancer
Being tested
Docetaxel, Doxorubicin, Cyclophosphamide, Docetaxel, Cyclophosphamide, Capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel, Doxorubicin, CyclophosphamideDrug

    docetaxel 75 mg/m², iv, day 1 doxorubicin 50 mg/m² or epirubicin 75mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 every 3 weeks for 6 cycles

  • Docetaxel, Cyclophosphamide, CapecitabineDrug

    docetaxel 75 mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 6 cycles

Study groups in NCT01354522
Study groupRoleWhat they receive
TACActive comparatordocetaxel 75 mg/m², iv, day 1 doxorubicin 50 mg/m² or epirubicin 75mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 every 3 weeks for 6 cycles
Receives: Drug: Docetaxel, Doxorubicin, Cyclophosphamide
TCXExperimentaldocetaxel 75 mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 6 cycles
Receives: Drug: Docetaxel, Cyclophosphamide, Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease-free survival

    the time from the date of surgery to locoregional or distant recurrence, second primary malignancy or death, whichever occurred first

    Measured: 10 years

  2. overall survival

    the time from the date of surgery to the date of death from any cause

    Measured: 10 years

Secondary outcomes (3)

  1. distant disease-free survival

    the time from randomization to distant recurrence of breast cancer

    Measured: 10 years

  2. Adverse event rate (CTCAE v. 4.0)

    Measured: 10 years

  3. disease-specific survival

    the time from randomization to deaths caused by breast cancer

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2023
  4. Study completionDec 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01354522
Sponsor's protocol ID
PUMCH-Breast-TCX
Status last verified
Jan 2014
First submitted
9 May 2011
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No

Publications

  • Song Y, Wang Y, Cao X, Xu Y, Zhou Y, Sun Q, Shen S. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide versus anthracycline plus docetaxel and cyclophosphamide regimen in women with high-risk, HER2-negative breast cancer: An open-label, randomized controlled trial. Cancer Commun (Lond). 2025 Sep;45(9):1113-1122. doi: 10.1002/cac2.70041. Epub 2025 Jun 9.

    PubMed 40491042

  • Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

    PubMed 34037241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Doxorubicin, Cyclophosphamide and Docetaxel, Cyclophosphamide, Capecitabine in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.

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 17 inclusion and 19 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: finished, as of the sponsor's last update on 15 Jun 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

disease-free survival (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT01354522, 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 15 Jun 2025.

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